Senior Manager, Corporate Quality - R&D Audits
- Pay
- $136,000 – $170,000 per year
- Location
- Bedford, MA · Hybrid
- Job type
- Full-time
- Level
- Director
- Experience
- 5+ years
- Education
- Bachelor's degree
- Listed
- 31 days ago
Skills & highlights for this role
- GPV auditing
- GLP/GCLP auditing
- ICH E6 GCP
- OECD GLP principles
- FDA regulations
Also useful
- EU requirements compliance
About the role
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives.
We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. Manager, Corporate Quality Audits, provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits.
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. The Opportunity to Make a Difference Primary responsibilities include: * Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors.
Develop audit plans, conduct quality audits, prepare audit reports, and communicate and escalate findings, including compliance risk. * Conduct Quality Audits associated with qualification of new vendors. * Conduct for cause audits of external vendors as requested by management. * Review and evaluate vendors audit response against current industry standards and guidelines to ensure sufficient controls are in place by the supplier to meet quality requirements. * Serve as a QA point of contact for vendor-related audits, performance oversight, and compliance decision-making. * Assist in the maintenance of the annual external audit schedules as requested by management. * Provie support during GXP health authority inspections * 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. * Assumes additional duties and responsibilities as assigned.
More about You Education and Skills
Pay and benefits
* Bachelor's degree in Life Sciences with 8+ years in pharmaceutical or biotech drug development.
Advanced degree preferred. * Minimum 5 years of experience in GPV a GLP/GCLP, including both external and internal auditing. * Extensive experience with OECD Principles on GLP, GPV, ICH E6 GCP Guideline, FDA Regulations and EU Requirements. * Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross-functional personnel at all levels. * Must be able to travel domestically and/or internationally 20% of the time.
What Now? We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $136,000 - $170,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package.
Equal opportunity and legal notices
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
From Sarepta's careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.
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Common questions
What is the salary for the Senior Manager, Corporate Quality - R&D Audits role at Sarepta?
The Senior Manager, Corporate Quality - R&D Audits posting at Sarepta states compensation of $136,000 – $170,000 per year. It is listed as a full-time position. Final pay may depend on location, experience, and interview evaluation on Sarepta's official career site.
Where is the Senior Manager, Corporate Quality - R&D Audits job at Sarepta located?
This Senior Manager, Corporate Quality - R&D Audits position at Sarepta is located in Bedford, MA (Hybrid). Always check Sarepta's application page for specific state eligibility or relocation policies.
What qualifications are required for Senior Manager, Corporate Quality - R&D Audits at Sarepta?
For the Senior Manager, Corporate Quality - R&D Audits role, Sarepta highlights 5+ years of relevant experience; a bachelor's degree; experience with GPV auditing, GLP/GCLP auditing, ICH E6 GCP, OECD GLP principles, FDA regulations. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Senior Manager, Corporate Quality - R&D Audits position at Sarepta?
This listing links directly to Sarepta's Workday application page. You can apply directly on Sarepta's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.