Director, Corporate Quality - GCP
Sarepta Therapeutics · Bedford, MA +1 more
QualityFull-time$186k–$232kCompany career page
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Role summary
Sarepta Therapeutics seeks a Director of Corporate Quality to provide strategic quality oversight across clinical development and real-world evidence programs. This role ensures GCP and GLP compliance across clinical trials and non-clinical studies, serving as a subject matter expert in regulatory standards and patient safety.
What they're looking for
- BS/BA in scientific discipline; advanced degree preferred
- 12+ years progressive experience in related industry
- 8+ years clinical quality assurance experience including internal and external audits
- Extensive knowledge of ICH Guidelines, FDA Regulations, and EU Requirements
- Experience supporting regulatory authority inspections preferred
- Experience developing and overseeing Quality Management Systems
- Strong interpersonal skills and ability to work cross-functionally at all levels
What you'll be doing
- Provide GCP and GLP quality assurance leadership and guidance to clinical and non-clinical stakeholders
- Partner with R&D functional leaders to resolve compliance issues at vendors and investigator sites
- Develop and implement corrective action plans in response to quality issues, audits, and inspections
- Develop study-specific audit plans, coordinate site selection, execution, and response activities
- Support inspection readiness activities and provide guidance during regulatory authority inspections
Privacy & handoff
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