Sr. Manager, QA Compliance

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.  We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness ​Financial Wellness Support for Caregivers   For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us   The Importance of the Role The Sr. Manager, QA Compliance, maintains GxP quality systems processes and procedures to drive quality compliance and business efficiencies. This position will work cross functionally with quality assurance operations, quality control, manufacturing, validation, Manufacturing Science &Technology (MS&T), and external vendors to gather, analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g., Product Quality Review, Quality Event Trending, clinical manufacturing in process and release/ stability data, laboratory controls data) to address adverse trends/ gaps as part of continuous improvement. This position will be responsible for tracking, management, and completion of Product Complaints as related to Sarepta’s commercial products. This position will be responsible for oversight of the Sarepta Product Recall process along with executing the Annual Mock Recall. The Opportunity to Make a Difference Responsibilities & Duties: Compliance Management: Responsible for tracking, management, and completion of cross functional areas Quality Records (such as deviations, lab investigations, change control, complaints, and CAPA) in partnership with applicable SMEs and leads error prevention and continuous improvement initiatives based on identified recurring root cause Maintain Quality Metrics and Key Performance Indicators (KPIs) in support of the quality record trending program. Owns and executes Quarterly/Annual trending of Quality records to identify adverse trends/risks to drive continuous improvement. Escalates to Quality Review Board, as applicable. Monitors, analyzes, and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time Risk Management Ensure the Quality Risk Management process is implemented in accordance with regulatory requirements (e.g., ICH Q9, GMP guidelines). Provides independent QA oversight for risk assessments across departments. Ensure that decisions (deviations, CAPA, changes controls, LIRs) are supported by appropriate risk evaluations. Audit Management Support Regulatory Inspections, Regulatory Submissions, Internal/External audits Support Observation response management from Regulatory Inspections, Regulatory Submissions, Internal/External audits Commercial Product Management Owner and SME of the Product Recall process. Responsible for managing Product Recalls/Annual Mock Recall. Responsible for escalation of Quality Defects to Health Authority agencies (FAR, BPDR) as applicable. SME of Product Complaint Management program including related quality documents and continuous improvement efforts. Responsible for tracking, management, and completion of Product Complaints as related to Sarepta’s