Executive Director, Research & Clinical Development QA

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

The Executive Director, Research & Clinical Development Quality Assurance provides senior leadership and strategic oversight for Quality Assurance activities supporting nonclinical (GLP/GCLP) and clinical development (GCP) programs, as part of Sarepta’s Corporate Quality organization.

This role is accountable for the effective execution of Quality Assurance responsibilities, including auditing, compliance oversight, and inspection readiness across critical phases of development, while maintaining appropriate independence from study execution teams. The Executive Director ensures Quality systems, processes, and controls are designed, implemented, and maintained in compliance with GLP, GCP, GCLP, and applicable regulatory requirements (FDA, OECD, ICH).

Operating within the Corporate Quality Organization, this role partners closely with Research, Clinical Development, Regulatory Affairs, and external partners (CROs, vendors, investigator sites) to foster a strong culture of quality, drive continuous improvement, and maintain inspection readiness in support of global development programs and regulatory submissions.

• Provide senior leadership and strategic oversight for Research & Clinical Development Quality Assurance activities within the Corporate Quality organization, supporting nonclinical (GLP/GCLP) and clinical development (GCP) programs across the development lifecycle.
• Lead an independent QA organization responsible for auditing, compliance oversight, and inspection readiness, while maintaining appropriate separation from study execution teams.
• Ensure Quality systems, processes, and controls are designed, implemented, and maintained in compliance with GLP, GCP, GCLP, and applicable regulatory requirements (FDA, OECD, ICH).
• Oversee QA review and oversight of nonclinical and clinical documentation, including protocols, amendments, study reports, investigator brochures, and data supporting regulatory submissions (e.g., INDs, BLAs, RFIs, PMRs).
• Lead and oversee audit programs covering internal processes, CROs, vendors, laboratories, and investigator sites, and ensure findings are effectively assessed, trended, and remediated through CAPAs.
• Partner closely with Research, Clinical Development, Regulatory Affairs, and external partners to provide risk‑based Quality guidance, drive continuous improvement, and maintain inspection readiness across global development programs.
• Oversee Quality Systems supporting development activities within Corporate Quality Organization, including deviations, CAPAs, change control, document management, and training.
• Recruit, develop, mentor, and lead QA managers and staff, building a high‑performing, scalable, and collaborative organization.

• Bachelor’s degree in Biomedical Sciences, Life Sciences, or a related field; advanced degree preferred.

• 12+ years of progressive experience in Pharmaceutical or Biotechnology Quality, including significant leadership experience in a QA and the GxP environment.
• Hands on experience in QA and have led a team
• Hands-on experience with cGMP manufacturing operations and oversight of CMOs.
• Direct experience supporting regulatory inspections and interactions with health authorities (e.g., FDA).

• Strong working knowledge of cGMPs, GLPs, GCPs, and applicable international Quality standards.
• Solid understanding of FDA GMP regulations, guidance, and compliance expectations.
• Proven ability to lead teams, influence cross-functional partners, and drive execution in complex environments.
• Demonstrated sound judgment, problem-solving skills, and attention to detail.
• Ability to balance operational execution with strategic thinking.
• Strong communication, interpersonal, and collaboration skills.
• Self-motivated, results-oriented, and adaptable in a fast-paced environment.

#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 $256,000 - $320,000 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.