Sarepta
Senior Manager, Corporate Quality – R&D Audits
Bedford, MA · Senior
No sponsorship$136k-$170kDetected 7 days ago
AuditingVendor ManagementFDA RegulatoryCRISPRLeadershipInternal AuditGxP
About the role
- The promise of genetic medicine has arrived, and Sarepta is at the forefront.
- In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
- Manager, Corporate Quality Audits, provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits.
Responsibilities
- The role ensures compliance with FDA, ICH, OECD, and other global requirements, supports the integration of acquired programs, and drives continuous improvement of quality systems.
- Develop audit plans, conduct quality audits, prepare audit reports, and communicate and escalate findings, including compliance risk.
- Support for Caregivers
- Revise and create GxP quality documentation, including SOPs, policies, templates, and work instructions.
- Manage auditing files, records, reports, licenses and certificates associated with the approved vendor program.
Requirements
- Candidates must be authorized to work in the U.S.
Compensation
- Assist in the maintenance of the annual external audit schedules as requested by management.
- The targeted salary range for this position is $136,000 - $170,000 per year.
Benefits
- Financial Wellness
- Provie support during GXP health authority inspections
- Sarepta Therapeutics offers a competitive compensation and benefit package.
Company info
- The Opportunity to Make a Difference
Equal opportunity
- Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Visa & Work Authorization
- Candidates must be authorized to work in the U.S.
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This listing is sourced directly from Sarepta's careers page and normalized into a canonical job model.