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Director, Global Enablement, Google Cloud

new44 minutes ago
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  • Ivy Exec
  • Sunnyvale
  • CA

Minimum qualifications: 10 years of field training and enablement experience with increasing responsibility, including people management experience. Experience in developing and managing sales competency models and learning paths for sales roles. Experience working with enterprise sales. Preferred qualifications: Experience working on strategy and vision for an integrated learning system behind the learning portal development for increased learner engagement and satisfaction. Working technical knowledge of a cloud technology platform. Ability to build relationships with internal stakeholders and external partners. Strategic thinker that can take broad visions and concepts and develop structured plans, actions and measurable metrics and then execute those plans. About the job As the Director of Global Enablement for Google Cloud, you will be responsible for leading the planning, design and implementation of global enablement programs across all regions and all go-to-market (GTM) segments. You will deliver productivity programs, enablement and business-supporting initiatives for Google Cloud Sales teams as well as Google Cloud product enablement to our customer-facing teams, including Sales, Customer Engineers, Professional Services and Channel. You will focus on long-term strategy and driving impact by working closely with all field roles, including direct sales and partners to support their enablement needs and ensure proper landing and execution of programs globally. Google Cloud helps millions of employees and organizations empower their employees, serve their customers, and build what’s next for their business — all with technology built in the cloud. Our products are engineered for security, reliability and scalability, running the full stack from infrastructure to applications to devices and hardware. And our teams are dedicated to helping our customers — developers, small and large businesses, educational institutions and government agencies — see the benefits of our technology come to life. Responsibilities Lead and inspire a global team of Enablement Program Managers responsible for driving higher productivity through programs like onboarding, continuing education, events, etc. Partner with Google Cloud Leadership and translate business needs into training products and programs. Oversee design, build and execute highly innovative and engaging learning programs enabling the field on knowledge, skills and tools/process. Ensure learning programs are with clear metrics on impact, effectiveness, appropriateness and utility. Drive an effective governance process focused on providing timely and targeted content and programs for enablement. Collaborate and drive continual improvements in our processes and productivity working with HR, Sales Operations and other subject matter experts across Google.

Software Engineer Associate

new44 minutes ago
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  • MSX International
  • Dearborn
  • MI

MSX International is currently seeking a Software Engineer Associate. Our company is transforming from a traditional industrial company to a contemporary digital industrial business, harnessing the power of cloud, big data, analytics, Internet of Things, and design thinking. In this role you will be responsible for developing end-to-end Industrial IoT Solutions for several products. The position works closely with product owners and PD engineers to define business problems and develop IoT technical solutions that meet customer requirements and expected outcomes. The successful candidate must have the following skills and experience: PCF Spring Springboot Java J2EE Education Required: Bachelor or equivalent experience Note: No Corp to Corp Candidates

Account Executive- Oncology- Portland

newabout 1 hour ago
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  • AbbVie

Perform all aspects of account management, including developing and maintaining strategic business relationships with corporate/senior management staff in key accounts with the goal of establishing multi-level relationships to increase representative access, develop new business, maximize resource utilization, and increase sales and market share of the assigned product. Key Responsibilities Include: Work with internal teams to manage and identify key target account opportunities. Develop product strategies to fully and consistently penetrate these accounts. Provide strategic and tactical direction regarding target accounts to regional and district teams. Advise sales and marketing management with appropriate direction on challenges and opportunities within key target accounts. Analyze and supports channel specific training needs within the Region. Develop an annual business plan with goals and objectives to increase sales volume and market share in target accounts across all FDA approved indications. Routinely identify local opportunities and threats and develop/modify business plans accordingly. Anticipate change and take proactive measures to address. Understand and effectively utilize a broad range of financial and quantitative data and analyses. Assess business impact of target account opportunities to include overall profitability and impact on sales. Partner with Field Sales Managers to evaluate and penetrate non-retail account drivers within MSAs. Drive target account volume and share growth through detailed analysis, providing recommendations and driving execution and pull through of District Managers and representatives. Basic: Bachelor's Degree required. At least 2 years sales or account management experience. Prefer a minimum of 3 years oncology experience Demonstrated ability to network and partner effectively across functional areas. Excellent organizational/project management and demonstrated leadership skills. Proven of managing multiple stakeholders in complex environments

3rd Shift Manufacturing Supervisor

newabout 1 hour ago
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  • AbbVie

Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions. Reviews all materials and batch records required to support shift and any off shift needs for the day. Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out. Monitors operator training files and work with compliance specialist to keep files up to date. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs. Works with technology transfer team to incorporate new processes in the plant. Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels. Ensures that direct materials budgets and overtime budgets are met. Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel. Evaluates staff performance. Level of position is commensurate upon education and experience of the candidate. Requires a Bachelor's degree or equivalent; Eight plus years' experience in all aspects of manufacturing/ production processes Computer proficiency and scheduling experience required; good writing skills. Working knowledge of safety, quality systems, and cGMPs is required Familiarity with industrial automation (e.g., distributed control and PLC-based systems Familiarity with equipment and facilities validation Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Account Executive, Urology

newabout 1 hour ago
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  • AbbVie

Work with internal teams to manage and identify key target account opportunities. Develop product strategies to fully and consistently penetrate these accounts. Provide strategic and tactical direction regarding target accounts to regional and district teams. Advise sales and marketing management with appropriate direction on challenges and opportunities within key target accounts. Analyze and supports channel specific training needs within the Region. Develop an annual business plan with goals and objectives to increase sales volume and market share in target accounts across all FDA approved indications. Routinely identify local opportunities and threats and develop/modify business plans accordingly. Anticipate change and take proactive measures to address. Understand and effectively utilize a broad range of financial and quantitative data and analyses. Assess business impact of target account opportunities to include overall profitability and impact on sales. Partner with Field Sales Managers to evaluate and penetrate non-retail account drivers within MSAs. Drive target account volume and share growth through detailed analysis, providing recommendations and driving execution and pull through of District Managers and representatives. Bachelor's Degree required. Minimum 2 years sales or account management experience. Prefer institutional experience (integrated systems, hospital networks, complex multi-call point). Demonstrated ability to network and partner effectively across functional areas. Excellent organizational/project management and demonstrated leadership skills. Proven record of managing multiple stakeholders in complex environments. Pharmaceutical experience at a level of district manager, managed care specialist, regional trainer, or higher preferred. Thorough understanding of account management and the role of an account executive as well as strong sales and customer partnership skills/success. Demonstrated ability to network and partner effectively across functional areas. Excellent organizational/project management and leadership skills. Urology experience preferred

Associate Scientist

newabout 1 hour ago
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  • Amgen

Amgen is seeking an Associate Scientist Process Development - Small Molecule Attribute Sciences to join our team and work from Amgen's beautiful Cambridge, Massachusetts campus. This position will be within an expanding Pivotal Process Development group. Key Responsibilities: A largely laboratory-based position where focus will be on driving cutting-edge analytical support and technology development impacting process and product development teams across Amgen's portfolio. Work cross-functionally and across R&D sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline. Basic Qualifications: Master's degree and 2 years of Scientific experience OR Bachelor's degree and 4 years of Scientific experience Preferred Qualifications: Master's degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering Training and expertise in analytical method development and organic chemistry or formulation development Demonstrated ability to analyze and interpret analytical data 3 plus year's in the pharmaceutical or biotech industry Strong understanding, research in, and hands-on experience with chromatographic techniques, such as Liquid chromatography and gas chromatography, as applied to pharmaceutical development Strong understanding, research in, and hands on experience with dissolution techniques for solid oral dosage forms. Strong technical aptitude for the identification, development, and implementation of novel analytical technologies, such as Mass spectrometry (MS), NMR, Vibrational spectroscopy etc. Structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry Familiarity with automation and implementing data management systems; ability to compile and communicate complex datasets in a manner in which facilitates informed decision-making Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment Strong abilities in trouble-shooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts at the pivotal phase of development Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high-unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Senior Specialty Representative, Neuro, Seattle South

newabout 1 hour ago
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  • Amgen

Territory: Seattle South (Neuro MH3C1A) Covering: Seattle South, Olympia, I-90 corridor No relocation assistance provided for this position. Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives. As a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients, we are actively searching for a Senior Specialty Representative to deliver on this commitment to patients. Amgen supports and encourages our team members to have long term, fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this opportunity to craft a long-term career with Amgen. The Senior Specialty Representative acts as the primary customer contact and is responsible for executing marketing strategy and promoting Amgen products as led by the District Manager. Our Senior Specialty Representatives achieve territory sales by utilizing their background and experience to: Provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products to medical professionals Perform as a sales leader to achieve territory sales by executing and delivering branded sales messages strategies. This includes: delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets Utilize internal and external relationships to service and manage accounts which includes: ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts Analyze business effectiveness of sales activities and territory analysis, as well as develop territory plans with the District Manager Have passion for our products and sustain that passion through the entire sales cycle while always building our brand, never losing sight of how we serve patients Partner with other colleagues to share best practices and be in a state of continuous curiosity and learning to help grow as a Senior Specialty Representative Leverage passion for disease state awareness, industry, regulatory and competitive changes to deliver agreed results Basic Qualifications: Bachelor's Degree and 3 years of sales experience OR Associate degree and 6 years of sales experience OR High school diploma/GED and 8 years of sales experience Preferred Qualifications: Three or more years of sales experience within pharmaceutical, biotech or medical device industry Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology, inflammation, cardiology, neurology, endocrinology, hepatology, gastroenterology or infectious diseases; and the diseases and treatments involved with these specialties Local market knowledge A Bachelor's degree in Life Sciences or Business Administration Adaptability with our Core Competencies: Planning and Organizing; Leveraging Business, Industry, and Technical Knowledge; Communicating with Impact; Driving for Results; and Cultivating Internal and External Relationships. Amgen is a Fortune 150 company operating in nearly 100 countries around the world. We invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.

Global Marketing Sr Manager, Oncology - Disease Area Strategy & Knowledge, GI Cancer, Gastric assets

newabout 1 hour ago
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  • Amgen

The Global Marketing Senior Manager will have responsibility for executing against key strategic marketing initiatives to support the early oncology portfolio, as well as the global marketing lead for one or more programs within the pipeline. Specific areas of responsibility include partnering with commercial excellence early oncology team to lead appropriate market research and insights generation projects to support development of portfolio, disease-state, and asset level strategies in the early stages of development, prior to pivotal / launch phase. The role will report to and assist the Director in preparing for various governance portals and liaise with cross-functional colleagues, vendors, Product Team members and archetype country New Product Development Leads to drive portal readiness. Key responsibilities include: Participate in (and lead) a variety of oncology strategic marketing projects covering Amgen's portfolio of immuno-oncology programs. Support effective progression of programs from one stage to another using disease state research, development of Patient Flows, SOC evolution, Competitive landscape and scenarios, TPPs (product profiles), forecasts, and generation of strategic options to maximize program value and return. Leverage deep customer, marketplace and competitor insights for oncology to create and/or support the creation of differentiated product and disease-state strategies. Partner with archetype country marketing to provide global perspectives and elicit/integrate regional insights into global strategies. Oversight of third party partners to develop, track, and overall manage project budgets. Contribute to the development of various molecules' Global Commercial Plan and Global Fact-book, as appropriate. Develop and maintain OL lists with program and indication orientation and support the Director in building strong relationships and gaining OL insights that help shape strategies Basic Qualifications Doctorate degree and 2 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Master's degree and 4 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Bachelor's degree and 6 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Associate's Degree and 10 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR High school diploma / GED and 12 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization Preferred Qualifications 5 years of biotech/pharmaceutical industry experience with strong experience in strategy development/consulting, and multiple facets of drug commercialization Oncology therapeutic area experience (marketing and/or scientific) with recognized depth in industry, technical and competitive dynamics that shape future oncology markets and needs Strong interpersonal skills with demonstrated ability to work and influence effectively within a matrix structure. Demonstrated ability to work with cross-functional partners to develop impactful program strategies that are based on market insights Knowledge of and experience in working with discovery research and clinical teams. Strong leadership skills, including ability to influence teams with diverse backgrounds. Strong competitive mindset, including ability to champion ideas, make decisions and focus on results Excellent written, analytical and verbal communication skills Strong business judgment and emotional intelligence Act as a role model for others in line with Amgen values About Amgen and Oncology/Hematology Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. For nearly four decades, Amgen has been at the forefront of providing the oncology and hematology communities with novel therapies that have changed patients' lives. We have 10 marketed oncology medicines available today, and we are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules. We need top talent to ensure these molecules become medicines and realize their potential for helping patients. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. At Amgen, contributions are recognized - and strong performance is rewarded. Regularly recognized as a "Best Place to Work," we enable staff to chart their own career paths based on their unique talents by offering challenging assignments, active career development, coaching and individual rewards. Join our team as we enter an era of oncology drug development that will usher in new wave of advances that promise to transform cancer care LI-POST

US Medical Communications Manager - Cardiovascular/Bone TA

newabout 1 hour ago
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  • Amgen

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients. Amgen is searching for a US Medical Communications Manager in our Cardiovascular & Bone therapeutic area. This manager will report to our Director of Medical Communications and will work out of our Thousand Oaks, CA corporate campus. The US Medical Communications Manager is responsible for developing high quality, scientifically rigorous resources that adhere to internal guidelines, SOPs, policies and industry regulations. This includes: Reviewing field-based promotional and educational materials for scientific accuracy as part of the Material Approval and Compliance (MAC) Responding to escalations from the US call center to help address external customer questions regarding Amgen products and pipeline molecules Developing de novo US Core Content to be used in regional medical communications and/or regionalizing global GCC resources for Medical Information and Regional Medical Liaisons Executing regional congress deliverables, disease state education programs and developing/adapting scientific content for online resources (e.g. websites, microsites, virtual congresses) Collaborating in a dynamic environment with multiple global and regional cross-functional teams Managing external providers and project-associated budgets. This manager can expect up to 10% domestic travel. Basic Qualifications: Doctorate degree OR Master's degree and 3 years of clinical, academic, or industry experience OR Bachelor's degree and 5 years of clinical, academic, or industry experience OR Associate's degree and 10 years of clinical, academic, or industry experience OR High school diploma / GED and 12 years of clinical, academic, or industry experience Preferred Qualifications: Doctorate degree (PharmD, PhD, MD, DO) with one or more years of cumulative experience in Medical/Scientific Affairs, Clinical Development, Clinical Research, patient care, and/or basic research Prior experience in Medical Affairs or Clinical Development within the biopharmaceutical industry (or clinical experience) in the Bone or Cardiovascular disease area Understanding of Scientific Communications projects including disease state education programs, advisory boards, congress/publication plans, and RML resources Understanding of Medical Information capabilities, literature surveillance, adverse event and product complaints requirements Experience with marketed products and late-stage pipeline products Excellent written, oral, and presentation skills and the ability to critically analyze the scientific literature to form logical opinions and communicate key business and clinical information at multiple levels An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products The ability to work in teams and interface in a dynamic environment across corporate functions Prior experience managing consultants and vendors We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. LI-POST

Postdoctoral Fellow - Computational/Systems Biology

newabout 1 hour ago
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  • Amgen

The Amgen Postdoctoral program is committed to providing future scientists with an enriching environment to inspire innovation that will contribute to the development of human therapeutics. Dr. Ramsey Saleem in the Attribute Sciences department at Amgen, Inc. is seeking a highly motivated Postdoctoral Fellow in the area of Computational Modeling. Amgen is seeking a computational biologist to assist in efforts to generate models of the cellular subsystems that are involved in production of biologics in CHO cells. Amgen's interest in this approach results from an applied, medically relevant problem, with significant financial consequences. We seek to understand our system at a level whereby we can systematically predict conditions which result in cells producing high levels of therapeutic proteins with the desired physical attributes. To this end we seek individuals to assist us in. Generate models of the cellular subsystems that are involved in production of biologics in CHO cells. These include but are not limited to: Golgi mediated N-linked glycosylation Transcription - chromatin remodeling, RNA processing and export Translation - ribosome assembly, ribosome progression Metabolic Flux Balance Optimize model parameters and refine to generate models with predictive value as done with the Golgi mediated N-linked glycosylation Link the models together so that the outputs from upstream subsystems provide inputs for downstream subsystems. Use in-house data to constrain the models and provide Amgen specific solution spaces for the models. The postdoctoral position is for 2 years with the option to extend for an additional year. Basic Qualifications PhD at the time of appointment Preferred Qualifications Demonstrated skill in the development of mathematical models of biological processes Experience in programming Expertise with statistics Candidates with a significant understanding of the biological underpinnings of protein production Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Process Development Associate - Drug Product Technology Department

newabout 1 hour ago
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  • Amgen

Job Description The Synthetics Enabling Technology Group within the Drug Product Technology Department (DPT) of Amgen at Thousand Oaks, CA is seeking an a Associate. SET is a key DPT interface with partners in Process Development, Discovery Research, and Translational Sciences, conducting molecule assessment of synthetics, staging molecules, identifying and executing strategies for discovery and early development. Within this space Synthetics Enabling Technologies: • Provides synthetics molecule assessment (developability assessment) and preclinical formulation support. • Enables lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile). • Utilizes predictive in silico and in vitro models to support molecule and biopharmaceutical assessments to identify development strategies. • Conducts the solid-state characterization and support DS and DP process development. • Provides early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and conducts technical transfers to support clinical manufacturing (GMP). This individual will support early structural elucidation of small molecules and their degradation products to support molecule assessment and formulation development. Basic Qualifications : Bachelor's degree OR Associate degree and 4 years of scientific or research experience OR High school diploma / GED and 6 years of scientific or research experience Preferred Qualifications: Bachelor's degree and 1 year of industrial experience in Pharmaceutics, Chemistry or related field. Experience in utilizing mass spectrometry (e.g. LC-MS) and a strong background in organic or analytical chemistry is highly desired Experience with preformulation techniques including HPLC, physical-chemical evaluation (solubility, stability, pKa and LogP determination, etc.) and solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, etc.) is beneficial. Computer competency and experience, particularly with Microsoft Excel and other data analysis software. Ability to take initiative, work independently, and be flexible in responsibilities is important. Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment are strongly desired. We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Associate Software Engineer - Supply Chain Analytics

newabout 1 hour ago
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  • Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Main Job Purpose: Amgen is seeking an Associate Software Engineer to join the Operations Information System organization. This position will partner with Supply Chain to build leading edge analytics applications. Our success is inspired by our dedication to our patients, to our business clients, and to using technologies that deliver critical business value. We value individuals who have high personal standards of productivity, quality and ethics. We value people who are intellectually curious and love learning. You will need to have the ability to quickly learn about the biotechnology operations value chain, including supply chain, logistics, and manufacturing systems. We are looking for someone who can work independently but values collaboration and learning from others. Key Activities include: You will evaluate and utilize state of the art technologies to meet Supply Chain business needs You will work directly with the supply chain business partners to develop analytics applications. You will review use cases, requirements and technical designs to identify areas of risk and write technical specifications, flow charts and drawings for your solutions. You will collaborate with the other engineering team members to ensure all services are secure, reliable, maintainable, and well-integrated into our existing platforms. You will be expected to follow standard methodologies for testing your solutions and develop and document reusable code. You will ensure effective communication between area management, technical staff and vendors. Basic Qualifications: Bachelor's degree OR Associate degree and 4 years of Information Systems experience OR High school diploma / GED and 6 years of Information Systems experience Requirements and Skills: Bachelor's Degree in Computer Science, Math, Supply Chain, or related field Data analysis and reporting experience using Tableau Experience in relational database fundamentals Proficiency in software development Aptitude for quickly learning new technologies and business processes Excellent communication and presentation skills Ability to juggle several projects simultaneously Preferred Skills: Make sure you highlight any of the following preferred skills in your application : Proficiency in Python Understanding of agile methodology Understanding of DevOps (Jenkins, JIRA, GitHub) Knowledge of supply chain management Anaplan or similar planning software configuration experience Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Sr. Clinical Trial Manager

newabout 1 hour ago
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  • Nektar Therapeutics

Position Overview The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures.Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. A Bachelor's degree or equivalent is required (life science degree is preferred). Typically an average of 8-10 years in the pharmaceutical industry is required, including but not limited to 4 years overseeing trial management. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Strong computer skills (MS Office) are required. Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent cross-functional clinical project management skills. Demonstrated ability to develop and implement SOPs and Study Plans. Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices is required. Fluent English is required. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

Head, Medical Project Management, Group Director

newabout 1 hour ago
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  • Bristol Myers Squibb Company

Summary The Head, Medical Project Management leads the project management organization that supports both the WW Medical and US Medical organization across both Oncology and our Innovative Medicines portfolio. This critical role will be a strategic and operational portfolio partner for the Head of Medical and the broader Medical Leadership team in identifying, planning and delivering on key portfolio related priorities. This includes leading key portfolio processes supporting Medical, Examples include data generation related ideation, prioritization (ISRs, BMS sponsored NRDG, HEOR), medical planning, Annual portfolio budgeting and tradeoffs, portfolio governance and decision making. The role will partner across key strategic and operational functions across the matrix (eg GCO, Finance, Development Project management, Business operations) to support a One Medical voice, prioritization and decision making. Key Responsibilities include but not limited to these below Lead, facilitate and support all portfolio related activities for Medical and the LT Lead annual portfolio processes by laying out an integrated timeline and approach for Medical planning, Medical Study BOW ideation, prioritization, budgeting and tradeoffs Lead the design and implementation of Functional governance for Medical, and through the project management team facilitate the necessary processes for approvals of medical plans and portfolio deliverables. Play a cross functional leadership role in identifying, designing and implementing strategic initiatives that impact the portfolio eg New ISR approval process, roll out of key portfolio tools and analytics Day to day management, coaching and leadership for the 15 project managers supporting the entire portfolio Leadership/advisory support for key initiatives for the MLT such as the roll out of the Medical operating model Lead/support the integration of the Celgene Medical portfolio with BMS internal portfolio Requirements BA/BS degree required; advanced degree preferred 10 years relevant experience preferred Experience in Medical and across a range of commercial and/or R&D roles a plus Experience in project management with the ability to develop clear action plans and execute People management experience preferred Ability to build relationships, influence and drive organizational engagement at all levels Highly effective written and verbal communication and interpersonal skills. Experience in budget management Comfort with ambiguity, driving change and innovation across a matrix Familiarity with portfolio process, budgets, tradeoffs a plus

Associate Automation Engineer

newabout 1 hour ago
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  • Bristol Myers Squibb Company

MAJOR DUTIES AND RESPONSIBILITIES Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions, Alarm management program and manufacturing support. Implement system modifications by following appropriate standard operating procedures. Troubleshoot and remediate system configuration/infrastructure issues. Collaborate in investigations of proprietary automation software/hardware problems with vendors. Communicate proactively with supervisor and colleagues, highlighting issues and proposing solutions. Participate in on-call support for Automation/IT systems with other team members. Follow applicable standard operating procedures while working in validated systems. KNOWLEDGE AND SKILL Bachelor's degree in Chemical Engineering, Electrical Engineering or equivalent combination of education and technical experience. A minimum of 4 years working experience with Control Systems or Building Automation Systems (BAS) or PLC's or manufacturing systems. Preferred experience in the following: Emerson DeltaV, PLC's or Rockwell Logix, OSISoft PI, Theoretical and applied knowledge of computerized systems and Systems Development Life Cycle. Working knowledge in computerized systems (Preferred Emerson DeltaV, OSISoft PI, or Rockwell Logix). Understanding of expectations working in regulated industries such as Biotech, Pharmaceutical, Medical Device or Food-Beverage is a plus. Must demonstrate an ability to understand and apply software solutions. Must demonstrate an ability to troubleshoot complex problems on highly automated equipment. Must be able to successfully work independently and within teams. Must be able to work in a fast paced multi-tasking environment. Must have strong interpersonal skills and ability to work in a team environment. Excellent verbal and written communication skills. CONTACTS Work both independently and in a team environment at all levels of the organization. Regular contact with internal departments and external business units to ensure alignment and occasional contact with related regulatory authorities. WORKING CONDITIONS Works in an office setting and GMP manufacturing environment. Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). DECISION MAKING Take action, final decision, recommend Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. SUPERVISION RECEIVED Limited direct supervision is required. Receives assignments in the form of objectives and establishes goals to meet deliverables as agreed upon with management. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions. SUPERVISION EXERCISED Project-based supervision of internal or external resources may be required.

Team Lead, Biomarker Operations

newabout 1 hour ago
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  • Bristol Myers Squibb Company

Strong senior contributor who also leads a team of individual contributors to drive strategic and tactical delivery of Biomarker activity at the asset level while ensuring rational alignment of asset strategy and protocol execution, including: Responsible for the design and evolution of the functional processes for, and drives individual development of, Program Level Biomarker Sample strategy documents (Laboratory Test Plan and Sample Risk Matrix) for a complex collection of assets under his/her accountability in close collaboration with one or more Biomarker Lead. Multi-functional team engagement and leadership Seeks opportunities to enhance value of external vendor relationships through early strategic engagement and ongoing partnership Drives the IT environment that delivers strategic documentation and supports the analysis of study designs vs. strategic plans. Team Leader who develops his/her staff in the application of a disciplined project approach to develop and execute operational plans to ensure delivery of Biomarker data to meet the requirements of the Program and the studies executing within them; documenting and managing associated issues and risks; setting agendas for operational program reviews and documenting outcomes, decisions and key learnings Responsible to evolve IT capabilities to enhance operational effectiveness in the initiation and oversight for request management of Biomarker assay development or sample analysis; ensures all work is documented in alignment with the protocol and the program strategy Independently or in partnership with one or more Biomarker Lead identifies and activates samples for analysis Collaborates with Execution Analysts to ensure effective sample movement through analysis and to final storage; partners with Biomarker Execution leadership to identify opportunities for increased leverage of internal and third party capabilities to drive sample execution Drives integration with clinical operations organization and data management to execute and streamline the processing for cleaning sample metadata as needed to ensure integrity of specimens and downstream analysis Experienced program manager counsels staff in the execution and maintenance of a clear Book of Work/Program Plan to facilitate cohesiveand uniform transparency across many projects and external partners; also, responsible for his/her own complex, highly visible, book of work Process owner for those processes and tools necessary to manage and triage critical, "systemic", issues for the Biomarker Operations function; ensures his/her staff maintains the discipline to document issues from identification through resolution. For his/her complex program of assets, maintains highest standard of program discipline and ensures learning is shared across the organization Demonstrates strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution Serves as TMES liaison to lead or support other strategic and process improvement initiatives affecting his/her platform area(s) as required Qualifications: B.S., M.S. in a scientific discipline; 8 yrs direct line management experience; with experience in Biomarker Operations or Clinical Study execution desired. 4 years of complex relationship management expertise e.g. vendor management, lab operations management Demonstrated knowledge of legal/regulatory environment governing sample management and informed consent; experience applying consistent interpretation for self and others as needed to drive compliant specimen use Demonstrated ability to establish a team mission/vision, define key metrics needed to measure organizational effectiveness, develop staff and grow a diverse team of individual contributors Balances team leader responsibilities and his/her own, complex, workload; strong voice to empower leadership and remove barriers for self and others. Sustains and demonstrates experience growing a diverse network within BMS and outside of BMS; leverages broad relationships to enhance personal and organizational outputs Experience establishing effective priorities for self and staff, while working with a sense of urgency, delivering on multiple projects and challenging, and often volatile, deadlines Experience designing effect business process flows and developing measures of process efficiency Skilled listener with ability to manage complex internal and external relationships through constructive conflict management; experience with third party governance oversight desirable Strong attention to detail and ability to work with high volumes of data independently and in collaboration with a multi-disciplinary scientific team; demonstrates mastery of and experience in coaching technical skills such as Excel and/or Spotfire Experienced in developing and implementing agile, creative solutions, utilizing direct and indirect resources, to solve business challenges within the line organization, across the company, and in partnership with external collaborators Highly collaborative, team leader and team-player who regularly seeks perspectives both within and outside of his/her direct accountability to develop and implement high value solutions

Associate Director, Market Portfolio Publication/Content Operations and Executive Lead Medical Capab

newabout 1 hour ago
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  • Bristol Myers Squibb Company

The Associate Director, Market Portfolio Publication / Content Operations and Execution Lead is responsible for ensuring that the Medical Capabilities, Markets (US, France, Germany, Japan, EMAC, and Intercon) teams drive against short-term and long-term business objectives. The position serves as the point of contact for Market Leads delivering operational leadership and execution excellence enabling successful delivery of publication and content priorities and team objectives. Key Responsibilities: Agency Leadership • Works in partnership with WW Publication and Content Leads and PPOE Leads to optimize strategic outsourcing partnerships including evaluating Agency performance (KPIs) and leading RFP initiatives for successful on-boarding and integration of new Agency partners • Serves as the principle (above asset) Market Medical Capabilities interface with Agency partners, holding them to the highest standards for productivity and ensuring optimal Agency support as publication and content needs evolve. Serves as the Market Publication Lead's first point of escalation on Agency-related performance issues • Continuously assess Agency resource model for defined span of control. Anticipates and proactively partners with WW and Market Publications and Content Leads and Agency Leadership to implement adjustments ensuring readiness to meet current and future business needs. Escalates risks appropriately to WW and Market Publications and Content Leads and Agency Leadership for action. Strategic Operations • Evaluates portfolio (above brand) level risks, identifying/reporting on barriers impacting timelines and deliverables, offering appropriate mitigation strategies • Continuously assesses Medical Capabilities, Markets model to identify simplified process improvement opportunities and identify resource allocation pressures/constraints and future risks offering alternatives strategies. Quickly escalates barriers to successful execution • Oversees annual Publication/Content Strategy Planning and Budget preparations ensuring clarity in timelines, deliverables and anticipating potential barriers to successful execution in collaboration with local Medical Coordinators/Specialists • Develops pro-active, cross-market publications and content metrics with key stakeholders including WW Publications & Content, WWMT leaders/project management, development team, key market and other key cross-functional stakeholders (e.g. congress updates, key TA level/multi-asset level communications) • Collaborate with cross-functional stakeholders including procurement, medical capabilities (WW Pubs and Content teams, Standards and Technology, Field Medical, Medical Information) to drive innovation and ensure business needs are met Execution Excellence • Partners with other portfolio (above brand) level cross-functional Operations lead to ensure publication-related needs are proactively communicated & appropriately prioritized enabling execution of publication commitments • Utilizes a variety of project management tools (Datavision) and financial systems (RPM/Ariba) to build and sustain high-performing publication teams Financial Stewardship • Continually assesses financial health of publication budget by evaluating committed/projected spends, adjusting WBS allocation as needed ensuring ongoing transparency into spend with Market Leads • Partners with Market Publication Leads to understand how the book of work will be delivered on budget. Maintains budget and projections in financial management systems (RPM) up to date serving as the point of contact between Medical Capabilities financial team, WWMT project management and Agencies. Accountable for ensuring projections and year-end financial discussions, reconciliations and service order close outs are completed within the required timelines Qualifications Requirements: • BS in business or health-science related field with 7 years of experience in the pharmaceutical or related healthcare industry or doctoral degree with commensurate experience • Demonstrated competence in publication field including execution across all phases of drug development and commercialization, good publication practices and guidance (GPP3, ICMJE), Sunshine Act, Pharma Code of Conduct, and other global guidance related to post-marketing practices, scientific data communication, and transparency & conflict-of-interest environments • Experience with change leadership and demonstrated success in leading across a cross-functional matrix team with excellent organizational, written & oral communication, facilitation, interpersonal and leadership skills • Proven experience effectively managing timelines and identifying resource needs and constraints and implementing strategies to meet changing needs/ requirements • Track record of success in leading complex projects. Demonstrated strong project management skills; Project management certification (PMP) a plus • Experience managing 3rd party vendors and influencing without authority • Certification as a Medical Publication Professional (CMPP) is desirable • Ability to travel domestically and internationally approximately 10-20% of time

Product Quality Complaints Analyst

newabout 1 hour ago
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  • Bristol Myers Squibb Company

Participate in the Global Product Quality Complaint (PQC) operations at the PQC Head Quarter (PQC HQ), with the primary responsibility of review and triage of incoming complaints. Facilitate communications for individual complaint records as necessary between PQC HQ function, Medical Information Contact Centers, Local Market representatives, internal sites, and external manufacturing operations. Identify any compliance gaps and inefficiencies and provide input in implementation of solutions. Support the management of the global complaint handling process from awarenss to closure ensuring quality & compliance with internal and regulatory requirements. Assist in other PQC related activites such as reconciliation processes, metrics generation, audit support, generation of ad hoc queries, etc. as directed by PQC management Primary responsibilities: Peform accurate review, evaluation and assignment of incoming product quality complaints within established timeframes Assess reported information for completeness and determine the complaint category/s, release/manufacturing/packaging site, local market and site PQC process owners, and ensure accurate and timely triage of incoming PQCs. As appropriate facilitate the collection of additional complaint information relevant for the investigation Assist in the product return, replacement and reimbursement processes for complaint investigation samples Ensure that complaints which require expedited review are identified and escalated to appropriate local markets, sites and senior management promptly per established procedures Resolve day-to-day triage assignment inaccuracies and issues Perform review and closure of PQCs upon completion of investigations per established procedure and timeframes Upon request by PQC HQ Management, perform the following support activities: Periodic product quality complaint metrics Generation of ad hoc reports Reconciliation of complaints received and transferred between organizations (e.g., Pharmacovigilance, Medical Information) to ensure allare documented as required in the Quality Management System for accountability of all PQC cases globally. Provide support during internal/external audits and inspections Provide backup coverage for the other day-to-day activities of the PQC HQ department, such as management of PQC general mailbox, SharePoint sites, archival of documents, etc. Provide support to Product Surety and Serialization management as requested Perform other duties as assigned by PQC HQ management. Degree: Minimum of a Bachelor's Degree required, Sciences, Pharmacy, Nursing, Chemical or Bio-Medical Engineering or related fields. Experience: A minimum of 7 years of pharmaceutical industry experience with at least 3 years in handling of Product Quality Complaints. Global experience working in mid to large biopharmaceutical with prescription drug dosage forms and combination products Skills and Competencies: Critical thinking to understand and operate under complex global environment. Demonstrated experience working with complex processes, detailed, organized, and ability to multi-task, balance conflicting priorities Excellent verbal and written communication in English Ability to work cross-fuctionally within the organization with all levels of leadership Ability to build strong relationships by being transparent, reliable and delivering on commitments In addition to English, bilingual ability in either of the languages - French/German/Spanish/Mandarin/Japanese will be preferred

Associate QC Scientist (Equipment Qualification, Lifecycle Management)

newabout 1 hour ago
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  • Bristol Myers Squibb Company

Bristol-Myers Squibb is seeking top talent for our Quality organization. The purpose of this evergreen req is to gather qualified candidates for an expected need in the near future. If you're interested in being contacted when this job becomes available, please apply and a recruiter will contact you when it does. Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The Bristol-Myers Squibb Devens site is a state-of-the-art biologics manufacturing facility located on 89 acres, just 45 minutes west of Boston. It is here that we will be fulfilling our critical mission to help patients prevail over serious diseases. This 400,000 square foot complex represents the single largest capital investment in the nearly 125 year history of BMS, $750 million, and is a key part of our strategic BioPharma transformation. Associate QC Scientist needed for the Quality Control Technical Support team in Devens, MA to lead and participate in analytical instrument qualification such as Chromatography systems, Immunoassay equipment, TOC, FTIR, SpectraMax L, AKTA, and Karl Fisher. Lead validation activities including development and execution of IQ/OQ/PQ Protocols/Reports and Lifecycle Management of instrumentation. Major Duties and Responsibilities: Lead and participate in analytical instrument qualification and validation activities including development and execution of IQ/OQ/PQ Protocols/Reports and Lifecycle Management of instrumentation. Execute equipment troubleshooting activities to support method performance and enhancements. Peer review and communication of instrument qualification in a concise, organized, and compliant manner. Identify and drive business improvement projects on site/across network. Author SOPs and training documents. Train and assist less experienced scientists within area of expertise. Support health authority inspections. Qualifications: Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Biological Sciences. A minimum of 4 years (MS) or 6 years (BS) relative experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab. Strong expertise in operational knowledge of analytical instruments and instrument qualifications. Knowledge of applicable business systems including: Trackwise, Maximo, MS Project. OpEx, Lean/Six Sigma, Yellow Belt recommended. Strong working background in QC laboratory systems and applications including LIMS sample manager, LES and their integration to other systems. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility. Strong problem solving ability, interpersonal, oral and written communication skills. Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals. Contacts: This role has business need to interact daily with any employee at any level of the Devens facility including members of the site Quality organization, other Quality staff, Automation, IT and Technical Services. Occasional contact from outside vendors. Working Conditions: Work is largely performed in a modern office and a cGMP laboratory/manufacturing facility where one must maintain a high attention to detail and be aware of the presence of workplace hazards including biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required in the laboratories. Decision Making: Works with peers to ensure alignment of priorities and agreement of project ownership. Supervision Received: Receives assignments in the form of objectives and established goals to meet objectives. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.

Manager, Global Product Quality Complaints

newabout 1 hour ago
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  • Bristol Myers Squibb Company

Accountable for supporting the establishment of Quality systems for the global management of Product Quality Complaints and supporting their maintenance in accordance with GMPs, global health authorities' requirements and expectations. Responsibilities: Lead the design and implementation of a robust and compliant global framework of GMP policies, directives, procedures and processes for quality risk management for product quality complaints Lead the establishment of a sustainable strategy for processes and procedures required for effective product quality complaint surveillance and investigation with Global Pharmacovigilance & Epidemiology Oversee, monitor and improve reconciliation processes to confirm receipt and entry of product quality complaints from intake sources requiring reconciliation such as but not limited to Medical Information Contact Centers, and Global Pharmacovigilance & Epidemiology. Lead the development and implementation of complaint investigation process improvements, liaise with ancillary groups for combination product/medical device complaints, oversee complaint quality risk management and surveillance activities for combination products, and participate in project teams as needed. Oversight, coordination of activities and assignments of complaint management teams, ensuring timelines and goals are met. Manage activities of the Product Quality Complaints Laboratory for investigation of customer-returned drug/device combination products Assist in the coordination and compliance with requests of regulatory authorities during internal inspections and during inspections of contract service providers as needed. Prepare complaint management and investigation reports, procedures and other documentation as needed. Monitor pre-defined deliverables within the scope of this position on a monthly basis and make adjustments in anticipation of changes to internal business and regulatory environment. Maintain awareness of evolving Product Quality Complaint global regulations and trends and implement systems to address potential GMP compliance impact Communicate effectively and build cooperative and supportive working relationships with responsible Product Quality Complaints headquarter, Product Quality Complaint investigation and Global Pharmacovigilance & Epidemiology surveillance teams, sites, and cross-functionally across BMS Active participation in pharmaceutical industry meetings, symposia, workshops to establish industry relationships, best practices and regulatory guidance as related to Product Quality Complaints Support the establishment and maintenance of Global Quality Product Quality Complaint metrics Identifies and recommends appropriate actions, activities and projects for continuous improvements Perform other duties as required Education: Minimum of a Bachelor's degree or higher in Biological Sciences, Chemistry or related science or engineering discipline Experience / Knowledge Desired: • A minimum of 10 years of pharmaceutical industry experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements • A minimum of 5 years experience and in-depth knowledge of GMP requirements of Global Product Quality Complaint management • Ability to effectively translate and communicate health authorities regulations • Cross-functional experience in three or more areas (i.e. Quality Assurance, Manufacturing, Packaging Technology, Supply Chain, Regulatory, Pharmacovigilance, etc.) is required • Experience with manager level interactions and influence with Manufacturing Operations, Pharmacovigilance, Regulatory, Medical Information, R&D and Supply Chain • Experience in Pharmaceutical or Biotech Manufacturing Operations • Collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites • Experience in managing cross-functional teams • Strong verbal and written communication skills • Excellent influencing, facilitation and project management skills • Subject matter expertise in regulatory requirements and expectations in Manufacturing, Pharmacovigilance, Quality Risk Management and/or Quality Assurance is required • Capability to build alignment with business partners including, commercial operations, pharmacovigilance, medical information and investigation site leaders • Strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives • Demonstrated ability to make and act on decisions while balancing speed, quality and risk • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights

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