Senior Manager, GMP Quality
Job in
Yonkers, Westchester County, New York, 10701, USA
Listed on 2026-08-14
Listing for:
SimulStat Incorporated
Full Time
position Listed on 2026-08-14
Job specializations:
-
Quality Assurance - QA/QC
-
Pharmaceutical
Job Description & How to Apply Below
Leading sponsor-side QA oversight of CMOs, the full-time Senior Manager, GMP Quality will manage quality activities across pre-clinical, clinical, and commercial manufacturing while working remotely on a 12-month contract.
Key responsibilities- Lead QA oversight for CMOs across various manufacturing stages, including drug substance and product
- Own quality oversight for commercial-stage drug substance activities, focusing on process validation and disposition
- Review and approve CMO documentation, batch records, and test data, and support regulatory submission quality reviews
- Bachelor's degree in a scientific or technical discipline
- 8+ years of GMP Quality experience in the pharmaceutical industry, particularly in late-stage drug product development
- Experience with sponsor-side CMO oversight in clinical-stage or commercial-stage drug substance activities
- Knowledge of process validation and regulatory submissions for late-stage and commercial products
- Preferred experience with inspection readiness, both domestically and internationally
Position Requirements
10+ Years
work experience
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