Executive Director, Research & Clinical Development QA

Sarepta is seeking an Executive Director, Research & Clinical Development QA to provide senior leadership and strategic oversight for Quality Assurance activities supporting nonclinical and clinical development programs. The role will oversee QA review and oversight of nonclinical and clinical documentation, lead audit programs, and partner closely with Research, Clinical Development, and Regulatory Affairs teams.

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).

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance