Bedford, Massachusetts, United States · Hybrid
$136k–$170k/yr
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 …
Skills: GCP compliance, Clinical quality assurance, Quality management systems, FDA regulations, ICH guidelines
Bedford, Massachusetts, United States · Hybrid
$161k–$201k/yr
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 …
Skills: Quality assurance, Sterile drug product, Batch record review, Lot disposition, Contract manufacturing
Cambridge, Massachusetts, United States · On-site
$161k–$201k/yr
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 …
Skills: Regulatory labeling, Clinical trial disclosure, Global regulatory strategy, CCDS development, US full prescribing information
Cambridge, Massachusetts, United States · Hybrid
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 …
Skills: Medical Strategy, Life-cycle Management, Data Generation, Scientific Narrative Development, Real-world Evidence
Andover, Massachusetts, United States · On-site
$78k–$98k/yr
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 …
Skills: Cell-based potency assays, Cell culture, SDS-PAGE, Western blot, Automated western blot
Columbus, Ohio, United States · Hybrid
$153k–$191k/yr
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 …
Skills: Biomarker discovery, Translational research, Neurobiology, Neuromuscular biology, siRNA therapeutics
Bedford, Massachusetts, United States · Hybrid
$136k–$170k/yr
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 …
Skills: GxP Oversight, Vendor Management, GPV Auditing, GLP Auditing, GCLP Auditing
Massachusetts, United States · Hybrid
$136k–$170k/yr
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 …
Skills: GxP Training Management, Veeva Training Vault, GLP, GCP, GVP
Cambridge, Massachusetts, United States · Hybrid
$186k–$232k/yr
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 …
Skills: Patient Advocacy, Drug Development, Clinical Trial Design, Strategic Collaboration, Stakeholder Management
Washington, District of Columbia, United States · Hybrid
$173k–$217k/yr
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 …
Skills: Consultative Selling, Clinical Selling, Account Planning, HCP Relationship Management, Product Launch
Columbus, Ohio, United States · On-site
$106k–$133k/yr
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 …
Skills: Biologics Preformulation, Developability Assessment, Biophysical Characterization, High-Throughput Formulation, Stability Studies
Bedford, Massachusetts, United States · On-site
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 …
Skills: International Supply Chain Operations, Global Distribution Planning, Inventory Management, Import/Export Documentation, Trade Compliance
Cambridge, Massachusetts, United States · Hybrid
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 …
Skills: Project Management, International Business Operations, Cross-functional Collaboration, Stakeholder Management, Pharmaceutical Industry Knowledge
Cambridge, Massachusetts, United States · On-site
$152k–$191k/yr
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 …
Skills: CRO Management, Clinical Trial Management, GCP/ICH Guidelines, FDA/EU Regulations, Budget Management
Cambridge, Massachusetts, United States · Hybrid
$161k–$201k/yr
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 …
Skills: Commercial Analytics, Business Operations, Tableau Development, Veeva CRM, Data Reporting
Bedford, Massachusetts, United States · Hybrid
$222k–$278k/yr
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 …
Skills: GVP Quality Oversight, Audit Strategy Design, Regulatory Compliance, Risk Mitigation, CAPA Management
Cambridge, Massachusetts, United States · Hybrid
$136k–$170k/yr
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 …
Skills: Commercial Forecasting, Data Analytics, Excel, Tableau, SQL
Cambridge, Massachusetts, United States · Hybrid
$256k–$320k/yr
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 …
Skills: Biostatistics, Clinical Development Strategy, Regulatory Submissions, SAS, R
Cambridge, Massachusetts, United States · Hybrid
$206k–$258k/yr
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 …
Skills: AI Architecture, Generative AI, AI/ML Engineering, Enterprise Architecture, Data Governance
Bedford, Massachusetts, United States · On-site
$112k–$140k/yr
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 …
Skills: Oligonucleotide Synthesis, Organic Chemistry, Multi-step Organic Synthesis, Solid-phase Synthesis, Peptide Synthesis
Bedford, Massachusetts, United States • Hybrid
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The Sr. Manager provides program-level quality oversight and strategic GCP compliance support across clinical development and real-world evidence portfolios. Responsibilities include leading integration of acquired programs, managing vendor risk, conducting audits, and driving continuous improvement in quality systems.
Candidates must hold a BS/BA in a scientific discipline with 8+ years of industry experience, including 6+ years in Clinical Quality Assurance. Extensive knowledge of global clinical trial conduct, ICH guidelines, and FDA regulations is required, with an advanced degree preferred.
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. 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
The Importance of the Role
The Sr. Manager, Corporate Quality – GCP, will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance, ensuring that all clinical trial activities meet FDA regulations, ICH guidelines, and applicable international standards.The Opportunity to Make a Difference
More about You
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.
Dragging Tomorrow Into Today.
Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. For information on our Community Guidelines, please visit sarepta.com/community-guidelines. We want to share a reminder with all job seekers and candidates regarding the persistence of recruiting fraud. Please read a message about recruiting fraud and steps you can take to protect yourself here: https://www.sarepta.com/recruiting-fraud
Offices: 215 First Street, Cambridge, MA 02142, US · 100 Federal St, Andover, Massachusetts 01810, US
Dragging Tomorrow Into Today.
Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. For information on our Community Guidelines, please visit sarepta.com/community-guidelines. We want to share a reminder with all job seekers and candidates regarding the persistence of recruiting fraud. Please read a message about recruiting fraud and steps you can take to protect yourself here: https://www.sarepta.com/recruiting-fraud
Offices: 215 First Street, Cambridge, MA 02142, US · 100 Federal St, Andover, Massachusetts 01810, US
