Manager, GMP Quality

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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

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