Senior Manager, Corporate Quality – R&D Audits
Sarepta Therapeutics · Bedford, MA
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Role summary
Sarepta Therapeutics seeks a Senior Manager for Corporate Quality to oversee vendor management and audit programs, ensuring GxP compliance with FDA and international standards. The role involves conducting GPV and GLP/GCLP audits, qualifying new vendors, preparing audit reports, and supporting regulatory inspections. Requires a bachelor's degree in life sciences with 8+ years in pharma/biotech development and 5+ years of auditing experience.
What they're looking for
- Bachelor's degree in life sciences; advanced degree preferred
- 8+ years pharmaceutical or biotech drug development experience
- 5+ years GPV and GLP/GCLP auditing experience, internal and external
- Deep knowledge of OECD GLP principles, ICH E6 GCP, FDA regulations, EU requirements
- Strong interpersonal skills, integrity, and cross-functional collaboration ability
- Ability to travel domestically and internationally 20% of the time
What you'll be doing
- Conduct external GPV and GLP/GCLP vendor audits; develop plans, reports, and communicate findings
- Perform quality audits for new vendor qualification and for-cause audits as needed
- Evaluate vendor audit responses and remediation against industry standards and guidelines
- Serve as QA liaison for vendor audits, performance oversight, and compliance decisions
- Create and revise GxP quality documentation including SOPs, policies, and work instructions
Privacy & handoff
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