Sr. Manager, QA Compliance

Role: Senior Manager, QA Compliance at Sarepta, overseeing GxP quality systems to ensure compliance and drive continuous improvement across manufacturing and quality assurance functions. Responsibilities include managing quality records (deviations, investigations, change control, complaints), maintaining quality metrics, executing trending analyses, and supporting risk management aligned with ICH Q9 and GMP standards. The role involves oversight of product complaint management, product recall processes, and supporting regulatory inspections and audits, with a focus on commercial biologics products for Duchenne muscular dystrophy and related indications. Qualifications: B.S. in Life or Health Sciences, with 10+ years in pharma/biotech, including 5+ years in QA/QE roles with GMP experience in biologics, globally compliant environments. Extensive knowledge of US GxP, EU GMP, and Veeva QMS required. Experience in managing product complaints, recalls, and FDA/EU inspections is essential. Skills include strong communication, cross-functional collaboration, negotiation, and risk management. The position is hybrid, based in the U.S., with some in-person engagement. High-value specifics: biologics, commercial manufacturing, GxP compliance, product complaints, recalls, regulatory inspections.