Director, Corporate Quality - GCP
Sarepta Therapeutics
Summary
The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta's Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
Job description
The Importance of the Role
The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta's Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
The Opportunity to Make a Difference
- Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations.
- 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, including coordination of responses.
- 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.
More about You
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 12+ years of progressive experience in a related industry.
- 8+ years' experience in Clinical Quality Assurance role, including experience with external and internal audits. Experience in a Non-Clinical Quality Assurance role is a strong plus.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
- Previous experience in supporting Regulatory Authority Inspections preferred.
- Previous experience in development and oversight of Quality Management Systems.
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
- This position may require up to 10% domestic and international travel.
Requirements
- BS/BA Degree in a scientific discipline
- 12+ years of progressive experience in a related industry
- 8+ years' experience in Clinical Quality Assurance role, including experience with external and internal audits
- Demonstrated experience working with clinical trial teams
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements
- Previous experience in development and oversight of Quality Management Systems
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels
- This position may require up to 10% domestic and international travel
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Company overview
Sarepta Therapeutics is a global biotechnology company headquartered in Cambridge, Massachusetts, focused on developing precision genetic medicines for rare diseases. Founded in 1980, the company has evolved into a commercial-stage biopharmaceutical leader with a specialized focus on RNA-based therapeutics and gene therapies. Sarepta's primary mission centers on treating devastating rare genetic disorders, particularly Duchenne muscular dystrophy (DMD), a progressive muscle-wasting disease affecting children. The company has developed multiple FDA-approved treatments including Exondys 51, Amondys 45, Vyondys 53, and the groundbreaking gene therapy ELEVIDYS. Sarepta employs approximately 1,300-1,400 professionals and maintains research facilities across multiple locations. The company's scientific platform leverages Morpholino oligomer technology for exon-skipping therapies and advanced adeno-associated virus (AAV) vectors for gene therapy delivery. With a market capitalization exceeding $2 billion, Sarepta continues to expand its pipeline to address additional rare diseases while building the world's largest gene therapy manufacturing capacity to accelerate patient access to transformative treatments.