Principal Product Quality Leader
About The Position
Amgen’s corporate Product Quality team is seeking a collaborative, highly motivated leader to provide technical expertise and leadership within a Product Quality Team. The role works with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments on product filings, program improvements, and investigations related to product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions, and inspections. The Principal Product Quality Leader supports one or more late-stage or commercial biologics products, providing technical expertise and project support to develop, implement, and manage strategies aligned with Product Development Team goals. The position owns, authors, and reviews GMP and regulatory documents; executes transactions in relevant GMP systems; and manages product data, including comparability assessments, annual product reviews, and product quality risk assessments. The role contributes to initiatives that ensure overall product health and supports the interface between research, global development, and manufacturing.
Requirements
- Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience; or a master’s degree and 4 years; or a bachelor’s degree and 6 years; or an associate degree and 10 years; or a high school diploma/GED and 12 years.
- Proficiency in communicating complex information orally and in writing to Product Quality leadership, peers, and regulatory agencies.
- Proficiency in cGMP knowledge and international regulatory expectations.
- Strong scientific data management and organization skills, with attention to detail.
- Analytical and problem-solving skills.
- Ability to work effectively with global, virtual teams.
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities, respond quickly to urgent requests, and meet challenging timelines.
- Team-oriented approach focused on achieving team goals.
Nice To Haves
- B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field.
- Increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
- 6+ years working in a regulated environment, either in direct GMP work or technical support, with experience working with biologic products.
- 1+ year of experience authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation.
Responsibilities
- Provide cross-functional quality leadership and support deliverables for late-phase and commercial programs.
- Support annual product reviews, specifications, comparability and stability programs, site and method transfers, and product quality impact assessments.
- Author Product Quality-owned regulatory filing sections and responses to questions (RTQs).
- Evaluate complex process and product quality data using science- and risk-based approaches.
- Develop patient-oriented strategies that account for business needs and provide solutions to complex issues.
- Own, author, and review GMP and regulatory documents.
- Execute transactions in relevant GMP systems and manage product data, including comparability assessments, annual product reviews, and product quality risk assessments.
- Engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments on product activities and investigations.
Benefits
- Health and welfare plans for staff and eligible dependents
- Retirement and Savings Plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
High school or GED
