Associate Director, GCP, RCDQA

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:
** 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.
The ideal candidate will operate with a high degree of independence, demonstrate strong leadership in cross-functional settings, and report directly to the Head of R&CD QA GCP/PV.
** The Opportunity to Make a Difference
*** Provide proactive GxP QA support and guidance to Clinical Trial Teams, leveraging analysis and interpretation of GxP regulations to ensure best practices in Clinical and QA operations.
* Lead integration of acquired clinical programs into existing quality frameworks, ensuring seamless transition of processes, systems, and compliance standards following mergers, acquisitions or partnerships.
* Partner with teams to resolve compliance issues identified at clinical vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
* Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
* Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
* Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
* Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
* Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
* Coordinate and manage external audit consultants, as needed to ensure quality and consistency.
* Perform other related duties and special projects, as assigned.
** 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…