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Manager, GMP Quality
Key Responsibilities
- Provide QA oversight of all Quality Control activities, including test method validations, product specifications, and stability programs
- Collaborate with internal and external stakeholders on deviation investigations, OOX investigations, CAPA plans, change controls, shelf-life extensions, and documentation revisions
- Partner with PDM/CMC, Supply Chain, Analytical Development, and other functions to support day-to-day GMP QA operations
- Serve as Quality SME for the execution of Quality Systems including Deviations, CAPAs, Change Controls, and related processes
- In partnership with Analytical Development, provide quality oversight and approval of method validations, specifications, release testing, and stability programs for Drug Substance and Drug Product
- Review and approve CMO documentation (specification documents, master batch records, label proofs, executed batch records, in-process and release test data) and perform product dispositions
Qualifications
- Bachelor’s degree in a scientific or technical discipline required
- Minimum 5 years of GMP Quality experience in the pharmaceutical industry; late-stage drug product development and validation experience preferred
- Strong technical background in small molecule process development, validation, and testing
- Knowledge of applicable US and global GMP regulations and industry standards
- Ability to evaluate and troubleshoot complex technical problems independently
- Strong cross-functional collaboration and communication skills; ability to manage multiple priorities under aggressive timelines