Director, Corporate Quality - GCP

Sarepta Therapeutics seeks a Director of Corporate Quality to provide strategic quality oversight across clinical development and real-world evidence programs. This role ensures GCP and GLP compliance across clinical trials and non-clinical studies, serving as a subject matter expert in regulatory standards and patient safety.

Responsibilities

• Provide GCP and GLP quality assurance leadership and guidance to clinical and non-clinical stakeholders
• Partner with R&D functional leaders to resolve compliance issues at vendors and investigator sites
• Develop and implement corrective action plans in response to quality issues, audits, and inspections
• Develop study-specific audit plans, coordinate site selection, execution, and response activities
• Support inspection readiness activities and provide guidance during regulatory authority inspections

Requirements

• BS/BA in scientific discipline; advanced degree preferred
• 12+ years progressive experience in related industry
• 8+ years clinical quality assurance experience including internal and external audits
• Extensive knowledge of ICH Guidelines, FDA Regulations, and EU Requirements
• Experience supporting regulatory authority inspections preferred
• Experience developing and overseeing Quality Management Systems
• Strong interpersonal skills and ability to work cross-functionally at all levels

Compensation: $185,600–$232,000 per year