Director, Global Quality & Regulatory Compliance

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World Evidence. You will ensure FDA/ICH compliance and partner with Clinical, Pharmacovigilance, and Research teams to uphold patient safety and scientific integrity.

In this hybrid role, you will drive CAPA programs, audits, inspection readiness, and continuous QMS improvements while supporting external and internal audits and regulatory inspections.

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 12+ years of progressive experience in a related industry.
• 8+ years in Clinical Quality Assurance role, including audits.
• Experience working with clinical trial teams.
• Extensive knowledge of ICH Guidelines, FDA Regulations and EU Requirements.
• Travel up to 10% domestically and internationally.

Responsibilities

• Provide leadership on GCP and GLP QA support to key clinical and non-clinical stakeholders.
• Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.
• Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
• Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
• Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
• Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution.
• Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
• Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
• Perform other related duties and special projects as assigned.

Skills

GCP QA

GLP QA

FDA Regulations

ICH Guidelines

QMS

Audits

Cross-functional teamwork

Regulatory inspections

Education

Bachelor's in science

Advanced degree preferred

Job description

Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World Evidence. You will ensure FDA/ICH compliance and partner with Clinical, Pharmacovigilance, and Research teams to uphold patient safety and scientific integrity.

In this hybrid role, you will drive CAPA programs, audits, inspection readiness, and continuous QMS improvements while supporting external and internal audits and regulatory inspections.