Manager, GMP Quality

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