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 Associate Director, Research & Clinical Development Quality Assurance (R&CD QA) will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance, ensuring that all clinical trial activities meet FDA regulations, ICH guidelines, and applicable international standards. As a core member of the Clinical Trial Team, the Associate Director will foster collaboration and deliver proactive QA guidance throughout the trial lifecycle. Responsibilities may include integration of acquired clinical programs into existing quality frameworks, vendor risk assessment and qualification, coordination and execution of investigator site audits, internal process audits, and inspection readiness activities. This role also drives continuous improvement in quality systems. More about You BS/BA Degree in a scientific discipline. Advanced degree preferred. 10+ years experience in a related industry. 8+ years experience in a Clinical Quality Assurance role, including experience with external and internal audits. Demonstrated experience working with clinical trial teams. Broad experience in conducting global clinical trials, along with a comprehensive understanding of relevant ICH Guidelines, FDA regulations, and EU requirements. Previous experience in supporting regulatory authority inspections preferred. Skilled in developing and managing Quality Management Systems. Strong interpersonal skills, integrity, professionalism, and ability to build effective relationships with staff across all levels. This position may require up to 10% domestic & international travel. What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.