Senior Manager, GCP Quality & Clinical QA

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 136,000 - 170,000; Full time

Job summary

Sarepta Therapeutics seeks a Sr. Manager, Corporate Quality - GCP to provide program-level QA oversight across clinical development and real‑world evidence, ensuring compliance with FDA, ICH, and international standards.

As a core member of the Clinical Trial Team, you will drive CAPA, vendor QA, site audits, and integration of acquired programs into quality frameworks, while promoting continuous improvement of quality systems.

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 8+ years experience in a related industry.
• 6+ years experience in Clinical Quality Assurance with audits.
• Extensive experience with global clinical trials and ICH/FDA/EU standards.
• Willingness to travel up to 10% domestically and internationally.

Responsibilities

• Provide proactive GCP QA leadership across Clinical Development and Real‑World Evidence.
• Lead integration of acquired programs into existing quality frameworks.
• Coordinate audits of investigator sites and internal processes.
• Develop CAPA plans and investigations in response to quality issues.
• Review regulatory submissions and trial documentation for compliance.
• Support inspection readiness activities and vendor risk management.
• Contribute to continuous improvement of GxP‑compliant QA procedures.

Skills

Interpersonal skills

Cross-functional collaboration

Analytical thinking

Quality systems knowledge

Education

BS/BA in scientific discipline

Advanced degree preferred

Job description

Sarepta Therapeutics seeks a Sr. Manager, Corporate Quality - GCP to provide program-level QA oversight across clinical development and real‑world evidence, ensuring compliance with FDA, ICH, and international standards.

As a core member of the Clinical Trial Team, you will drive CAPA, vendor QA, site audits, and integration of acquired programs into quality frameworks, while promoting continuous improvement of quality systems.