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Senior Manager, GMP Quality
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-08-31
Listing for:
Apr
Full Time
position Listed on 2026-08-31
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist, Medical Science
Job Description & How to Apply Below
Senior Manager, GMP Quality
Remote, 12-month contract
Key Responsibilities- Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing - drug substance, drug product, and final product
- Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
- Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
- Review and approve CMO documentation, batch records, and test data; perform product dispositions
- Support quality review of regulatory submissions (IND/IMPD, NDA) and participate in inspection readiness
- Represent QA cross-functionally with CMC, Supply Chain, and Analytical Development
- Maintain quality metrics and periodically revise GMP SOPs
- Bachelor's degree in a scientific or technical discipline
- 8+ years GMP Quality experience in pharma, including late-stage drug product development and validation
- Sponsor-side CMO oversight experience - clinical-stage across DS/DP/FP, or commercial-stage specifically on drug substance
- Experience with process validation (PPQ) and late-stage/commercial regulatory submissions
- Inspection readiness experience (domestic and/or ex-US) preferred
Position Requirements
10+ Years
work experience
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