Associate Director, GCP, RCDQA

Role Summary

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. 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.

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.

Qualifications

• Required: 10+ years experience in a related industry.
• Required: 8+ years experience in a Clinical Quality Assurance role, including experience with external and internal audits.
• Required: Demonstrated experience working with clinical trial teams.
• Required: Broad experience in conducting global clinical trials, along with a comprehensive understanding of relevant ICH Guidelines, FDA regulations, and EU requirements.
• Preferred: Previous experience in supporting regulatory authority inspections.
• Required: Skilled in developing and managing Quality Management Systems.
• Required: Strong interpersonal skills, integrity, professionalism, and ability to build effective relationships with staff across all levels.

Education

• BS/BA Degree in a scientific discipline. Advanced degree preferred.

Additional Requirements

• Travel: Up to 10% domestic and international travel.