Senior Manager, GMP Quality

Senior Manager, GMP Quality leads QA for commercial finished product (FP) batch review, disposition, and release activities to ensure timely, compliant release of commercial product. Oversees review and approval of batch records, deviations, investigations, analytical data, CoAs, and release documentation for FP disposition. Provides QA oversight for commercial manufacturing, packaging, labeling, testing, storage, and release at CMOs, contract labs, and distribution partners. Collaborates cross-functionally with PDM/CMC, Supply Chain, Regulatory Affairs, Technical Operations, Validation, and external partners to maintain uninterrupted commercial product supply. Represents QA on cross-functional teams, guiding quality and compliance questions using current global regulations and best practices. Supports deviation investigations, CAPA plans, change controls, product impact assessments, complaints, recalls, annual product reviews, and other GMP quality systems. Ensures compliance with FDA, EMA, ICH, and other global GMP regulations governing commercial manufacturing and product release. Maintains quality metrics related to batch disposition timelines, deviations, product quality trends, and overall effectiveness of commercial quality systems, communicating risks to senior management. Leads periodic review and revision of GMP-related SOPs, work instructions, and quality procedures to align with evolving regulatory expectations and business needs. Supports quality review of regulatory submissions and post-approval filings (NDA supplements, annual reports, responses to health authority inquiries). Builds positive relationships and fosters a culture of quality, accountability, collaboration, and continuous improvement across internal teams and external partners.