Senior Manager, GMP Quality
SimulStat
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Remote, 12-month contract
Senior Manager, GMP Quality
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
Qualifications
- 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
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