Executive Director, Research & Clinical Development QA

Sarepta Therapeutics • Bedford, MA

4d • Hybrid

About The Position

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 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.

Requirements

• 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.
• Willingness to travel up to ~20–25% as needed.

Responsibilities

• 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.

What This Job Offers

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