The Senior Quality Manager, GMP leads sponsor-side GMP quality oversight for CMOs/CDMOs supporting pre-clinical, clinical, and commercial manufacturing of drug substance, drug product, and final products. This role is responsible for quality systems, CAPA, deviations, change controls, batch record review, product disposition, process validation/PPQ, regulatory submissions, and inspection readiness. The position works closely with CMC, Supply Chain, Analytical Development, Manufacturing, and external manufacturing partners to ensure compliance, product quality, and successful delivery of clinical and commercial programs.
- 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
- 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