Associate Director, GCP, RCDQA

Sarepta Therapeutics • Bedford, MA

3d • Hybrid

About The Position

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.

Requirements

• 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.
• Candidates must be authorized to work in the U.S.

Responsibilities

• 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.

Benefits

• Sarepta Therapeutics offers a competitive compensation and benefit package.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director