Director, Corporate Quality - GCP

Sarepta Therapeutics•Bedford, MA

4d•Hybrid

About The Position

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.

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.
Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

Nice To Haves

Advanced degree preferred.
Experience in a Non-Clinical Quality Assurance role is a strong plus.
Previous experience in supporting Regulatory Authority Inspections preferred.
Previous experience in development and oversight of Quality Management Systems.

Responsibilities

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.