Senior Manager, GMP Quality

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 Required qualifications 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 #J-18808-Ljbffr SimulStat Incorporated