Sr. Manager, Corporate Quality - GCP
Sarepta Therapeutics
August 11, 2026
Remote friendly (Bedford, MA)
United States
Corporate Functions
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 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 post-merger/acquisition/partnership.
- 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 related to quality issues, audits, and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance.
- Develop and maintain study-specific audit plans; support audit preparation, site selection, execution, and response coordination.
- Contribute to implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System.
- Support inspection readiness and provide guidance/hands-on support during GxP inspections.
- Coordinate and manage external audit consultants as needed.
- Perform other related duties and special projects as assigned.
Qualifications/Requirements:
- BS/BA in a scientific discipline; advanced degree preferred.
- 8+ years experience in a related industry.
- 6+ years in Clinical Quality Assurance, including external/internal audits.
- Demonstrated experience working with clinical trial teams.
- Extensive global clinical trial conduct experience; knowledge of ICH Guidelines, FDA Regulations, and EU Requirements.
- Prior support of Regulatory Authority Inspections preferred.
- Prior development/oversight of Quality Management Systems.
- Excellent interpersonal skills and ability to work cross-functionally.
Skills/Additional:
- Ability to gain trust and build relationships at all levels.
- Up to 10% domestic and international travel.
Application:
- Candidates are encouraged to apply.
Hybrid/Authorization:
- Hybrid role; work on-site at U.S. facilities and occasional in-person events.
- Candidates must be authorized to work in the U.S.
Responsibilities:
- Provide proactive GCP QA support and guidance to Clinical Trial Teams.
- Lead integration of acquired clinical programs into existing quality frameworks post-merger/acquisition/partnership.
- 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 related to quality issues, audits, and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance.
- Develop and maintain study-specific audit plans; support audit preparation, site selection, execution, and response coordination.
- Contribute to implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System.
- Support inspection readiness and provide guidance/hands-on support during GxP inspections.
- Coordinate and manage external audit consultants as needed.
- Perform other related duties and special projects as assigned.
Qualifications/Requirements:
- BS/BA in a scientific discipline; advanced degree preferred.
- 8+ years experience in a related industry.
- 6+ years in Clinical Quality Assurance, including external/internal audits.
- Demonstrated experience working with clinical trial teams.
- Extensive global clinical trial conduct experience; knowledge of ICH Guidelines, FDA Regulations, and EU Requirements.
- Prior support of Regulatory Authority Inspections preferred.
- Prior development/oversight of Quality Management Systems.
- Excellent interpersonal skills and ability to work cross-functionally.
Skills/Additional:
- Ability to gain trust and build relationships at all levels.
- Up to 10% domestic and international travel.
Application:
- Candidates are encouraged to apply.
Hybrid/Authorization:
- Hybrid role; work on-site at U.S. facilities and occasional in-person events.
- Candidates must be authorized to work in the U.S.