Senior Manager, GMP Quality

Job Summary

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