Senior Quality Manager, GMP

Job Description

Job Description

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.