Product Quality Director
Amgen · Remote
QualityRemoteFull-timeCompany career page
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Role summary
Amgen seeks a Product Quality Director to serve as Product Quality Leader for late-phase and commercial biopharmaceutical programs. This role provides technical expertise and strategic leadership across quality functions, including stability programs, regulatory submissions, and GMP compliance, while managing a product quality team.
What they're looking for
- Doctorate degree and 4 years quality/operations/scientific/manufacturing experience, or equivalent
- Master's degree in chemistry, biochemistry, biology, or related biotechnology field preferred
- 8+ years pharmaceutical experience with increasing responsibility in quality or related functions
- 6+ years direct GMP experience in regulated environment
- 5+ years managing staff with increasing responsibilities
- 2+ years as Product Quality Leader or technical product champion
- Knowledge of cGMP, large molecule development, product stability, and regulatory filings
What you'll be doing
- Lead product quality activities including stability programs, specifications, comparability, and annual product reviews for development and commercial products
- Manage complex, long-term deliverables for late-phase and commercial programs, including regulatory filing sections and change control execution
- Provide scientific oversight and risk-based evaluation of process and product quality data, developing patient-oriented strategies
- Communicate complex quality information effectively to leadership, peers, and regulatory agencies during inspections
- Mentor and develop product quality team members to build core competency in quality functions
Privacy & handoff
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