New · posted Oct 15
Sarepta Therapeutics · Biotechnology
Director, Corporate Quality - GCP
- Bedford, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
The Importance of the Role
The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
The Opportunity to Make a Difference
Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations.
Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.
Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
Perform other related duties and special projects as assigned.
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. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
More about You
BS/BA Degree in a scientific discipline. Advanced degree preferred.
12+ years of progressive experience in a related industry.
8+ years’ experience in Clinical Quality Assurance role, including experience with external and internal audits. Experience in a Non-Clinical Quality Assurance role is a strong plus.
Demonstrated experience working with clinical trial teams.
Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
Previous experience in supporting Regulatory Authority Inspections preferred.
Previous experience in development and oversight of Quality Management Systems.
Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
This position may require up to 10% domestic and international travel.
What you need
Pay and benefits
$186,000 – $232,000 a year
Employer providedWhat 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.
Physical and emotional wellness
Financial wellness
Support for caregivers
Competitive compensation and benefit package
Where you'll work
Bedford, MAHybridOpen in Maps (opens in a new tab)
More jobs in Bedford, MAFrom the posting
About Sarepta Therapeutics
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.
Equal opportunity, accessibility and legal noticesSarepta Therapeutics's statements, word for word
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 $185,600 - $232,000 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 to, 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.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $186,000 | — | $232,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Sarepta Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Sarepta Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership5
- Documentation and SOPs2
- Investigations and CAPA2
- Quality systems and risk2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Sarepta Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 3
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Director2 50%
- Manager2 50%
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Director, Corporate Quality - GCP at Sarepta Therapeutics
Open until filled. $186K–$232K a year, employer provided.