Quality Assurance Senior Manager
About The Position
The Quality Assurance Senior Manager is responsible for quality oversight of primary component suppliers and serves as an integral member of Amgen’s cross-functional supplier teams, working with groups including business operations, process development, supply chain, and combination product quality. The role oversees supplier relationships from onboarding through disengagement, promotes supplier performance through proactive monitoring and continuous improvement, and ensures compliance with global regulatory standards and Amgen expectations. The position may be based on-site in Thousand Oaks, California; Cambridge, Massachusetts; Greenwich, Rhode Island; Tampa, Florida; or Puerto Rico, and is also open to remote associates anywhere in the United States. Up to 20% domestic and international travel is required.
Requirements
- One of the following education and Quality experience combinations: doctorate degree and 2 years; master’s degree and 4 years; bachelor’s degree and 6 years; associate’s degree and 10 years; or high school diploma/GED and 12 years.
- Up to 20% domestic and international travel is required.
Nice To Haves
- 10 or more years of biotech or pharmaceutical industry experience.
- 5 or more years of experience overseeing supplier quality.
- Experience leading audits.
- Technical knowledge related to primary components.
- Experience with quality processes and systems such as Trackwise and Veeva.
- Experience overseeing the quality of primary components.
- History of presenting during inspections and audits.
- Ability to facilitate and influence senior stakeholders and partners.
- Ability to prioritize workload successfully and meet timelines.
- Ability to negotiate a strategic position after receiving feedback from multiple sources.
- Strong project management, problem-solving, and analytical skills.
- Demonstrated ability to lead cross-functional teams and consistently deliver timely, high-quality results.
- Ability to collaborate and communicate effectively, balance divergent input from partners, and drive issue resolution.
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
- Experience managing relationships with external parties.
- Familiarity with data and artificial intelligence tools.
Responsibilities
- Act as the quality lead for supplier relationships from onboarding through disengagement, supporting performance through proactive monitoring, technical site visits, and continuous improvement.
- Manage supplier quality proactively and ensure compliance with applicable global regulatory standards, including GDP, GMP, and ISO, as well as Amgen expectations.
- Negotiate and own quality agreements.
- Prepare external sites for inspections, including developing inspection playbooks.
- Represent Amgen at supplier sites during product-specific regulatory inspections and, when applicable or required, notified body audits.
- Present on topics during inspections and demonstrate appropriate behaviors and subject-matter knowledge.
- Review and approve supplier investigations, events, and change notifications.
- Approve deviations, change controls, CAPA, and CAPA effectiveness verifications as the quality approver.
- Identify and mitigate supplier risks or escalate them to management.
- Perform Person in Plant activities as appropriate.
- Drive audit commitments to completion.
- Lead supplier audit preparation and identify areas of focus.
- Continuously assess supplier status through periodic monitoring reports.
- Partner with the Operations site lead on issues, improvements, site performance, and relationship management.
- Understand and implement GMP requirements internally and externally.
Benefits
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and 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
Senior
Education Level
No Education Listed
