Global Quality & Compliance Director, GCP/GLP

Sarepta Therapeutics; Bedford (MA); On-site; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics seeks a Director, Corporate Quality to provide leadership and strategic quality oversight across Clinical Development and Real-World Evidence. You will ensure GCP/GLP compliance and collaborate with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research.

You will lead CAPA, audits, and inspections, develop QA strategies, and support end-to-end regulatory compliance and patient safety.

Qualifications

• GCP/GLP QA expertise required across Clinical and Non-Clinical
• Experience coordinating regulatory audits and inspections
• Strong cross-functional collaboration with Clinical Development, QA, Pharmacovigilance
• Proven ability to implement and maintain Quality Management Systems
• Experience supporting Regulatory Authority Inspections preferred

Responsibilities

• Provide leadership on GCP/GLP QA across Clinical Development, Real-World Evidence, and QA operations.
• Act as primary Quality partner to R&D functional leaders.
• Develop CAPA plans and investigations in response to quality issues, audits, and inspections.
• Review clinical trial documentation for completeness and compliance with requirements.
• Develop and maintain study-specific audit plans and assist in audits.
• Support inspection readiness activities for sponsors, monitors, and sites.
• Perform related duties and special projects as assigned.

Skills

GCP/GLP QA expertise

Audits coordination

Cross-functional collaboration

Quality management

Education

BS/BA in science

Advanced degree preferred

Job description

Sarepta Therapeutics seeks a Director, Corporate Quality to provide leadership and strategic quality oversight across Clinical Development and Real-World Evidence. You will ensure GCP/GLP compliance and collaborate with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research.

You will lead CAPA, audits, and inspections, develop QA strategies, and support end-to-end regulatory compliance and patient safety.