Sr. Manager, QA Compliance

Role: Senior Manager, QA Compliance, overseeing GxP quality systems to ensure regulatory compliance and operational efficiency within Sarepta's biopharmaceutical manufacturing environment. Responsibilities include managing quality records (deviations, complaints, CAPA), maintaining quality metrics and KPIs, conducting trending analysis and risk assessments, supporting regulatory audits and inspections, and managing product recalls and complaint processes. The role involves cross-functional collaboration with quality assurance, manufacturing, validation, and external vendors to address quality trends and implement continuous improvement initiatives. Qualifications: B.S. in Life Sciences or related field, with 5+ years of QA or Quality Engineering experience in biologics or pharmaceuticals, including GMP operations and global compliance (US and EU). Extensive knowledge of GxP regulations, quality management systems (Veeva), and experience with product complaint handling, risk management, and regulatory inspections. High-value specifics include expertise in commercial biologics, GMP compliance, and product recall management. The position is hybrid, based in the U.S., with some in-person requirements; travel is not specified.