Sr. Manager, Corporate Quality - GCP
Sarepta Therapeutics
August 11, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
The Sr. Manager, Corporate Quality – GCP, will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio, serving as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance to ensure clinical trial activities meet FDA regulations, ICH guidelines, and applicable international standards.
Responsibilities:
- Provide proactive GCP QA support and guidance to Clinical Trial Teams.
- Lead integration of acquired clinical programs into existing quality frameworks.
- Partner with teams to resolve compliance issues at clinical vendors and investigator sites; assess impact and recommend corrective actions.
- Assist in development and implementation of CAPA plans and investigations.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance.
- Develop and maintain study-specific audit plans; support audit preparation, site selection, and execution.
- Contribute to implementation and continuous improvement of GxP-compliant procedures and operations for clinical Quality Management Systems.
- Support inspection readiness for sponsors, monitors, and sites; provide guidance during GxP inspections.
- Coordinate/manage external audit consultants as needed.
- Perform other related duties and special projects as assigned.
Qualifications:
- BS/BA in a scientific discipline; advanced degree preferred.
- 8+ years related industry experience.
- 6+ years in Clinical Quality Assurance, including internal/external audits.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with global clinical trial conduct; knowledge of ICH, FDA, and EU requirements.
- Previous experience supporting Regulatory Authority Inspections preferred.
- Previous experience developing/overseeing Quality Management Systems.
- Excellent interpersonal skills and ability to build cross-functional relationships.
- Up to 10% domestic and international travel.
Application instructions:
- Apply if comfortable with ambiguity and candor; place kindness and integrity at the forefront of how you work.
Responsibilities:
- Provide proactive GCP QA support and guidance to Clinical Trial Teams.
- Lead integration of acquired clinical programs into existing quality frameworks.
- Partner with teams to resolve compliance issues at clinical vendors and investigator sites; assess impact and recommend corrective actions.
- Assist in development and implementation of CAPA plans and investigations.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance.
- Develop and maintain study-specific audit plans; support audit preparation, site selection, and execution.
- Contribute to implementation and continuous improvement of GxP-compliant procedures and operations for clinical Quality Management Systems.
- Support inspection readiness for sponsors, monitors, and sites; provide guidance during GxP inspections.
- Coordinate/manage external audit consultants as needed.
- Perform other related duties and special projects as assigned.
Qualifications:
- BS/BA in a scientific discipline; advanced degree preferred.
- 8+ years related industry experience.
- 6+ years in Clinical Quality Assurance, including internal/external audits.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with global clinical trial conduct; knowledge of ICH, FDA, and EU requirements.
- Previous experience supporting Regulatory Authority Inspections preferred.
- Previous experience developing/overseeing Quality Management Systems.
- Excellent interpersonal skills and ability to build cross-functional relationships.
- Up to 10% domestic and international travel.
Application instructions:
- Apply if comfortable with ambiguity and candor; place kindness and integrity at the forefront of how you work.