Senior Manager, Quality Control GMP

Job Summary

Providing scientific and technical leadership for Quality Control activities, the remote Senior Manager, Quality Control GMP will manage method lifecycle, ensure GMP compliance, and support release and stability testing strategies for drug substances and products.

Key responsibilities:

• Lead QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substances and products
• Serve as a subject matter expert for release and stability testing, overseeing data review and trending
• Manage investigations of deviations and OOS/OOT results, including root cause analysis and CAPA development

Required qualifications:

• Ph.D. in Chemistry, Pharmaceutical Sciences, or related discipline, or M.S./B.S. with substantial relevant experience
• 5-8 years of experience in QC testing and GMP compliance for clinical and/or commercial programs
• Strong expertise in analytical techniques for small molecule pharmaceuticals
• Deep understanding of method validation, transfer, and lifecycle management in regulated environments
• Experience overseeing external laboratories, CMOs, or CROs