Director, Corporate Quality - GCP

Socket.dev; Bedford (MA); Hybrid; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics is seeking a Director, Corporate Quality to provide leadership and strategic quality oversight across Clinical Development and Real-World Evidence portfolios. You will be the SME for GCP and GLP compliance, ensuring trials and studies meet FDA regulations and ICH guidelines.

In this hybrid role, you will partner with Clinical Development, Operations, Pharmacovigilance and Research to drive end-to-end regulatory compliance, scientific integrity, and patient safety across

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 12+ years of progressive experience in a related industry.
• 8+ years in Clinical Quality Assurance with audits.
• Experience with global clinical trials and regulatory guidelines.
• Experience supporting regulatory authority inspections preferred.

Responsibilities

• Provide leadership on GCP/GLP QA support to key stakeholders across Clinical/Non-Clinical/QA operations.
• Act as primary QA partner to R&D leaders across Clinical, Non-Clinical, Research & Pharmacovigilance.
• Partner with teams to resolve compliance issues at vendors/sites; assess deficiencies and recommend actions.
• Develop and implement CAPA plans and investigations in response to quality issues, audits, inspections.
• Review clinical trial documentation and regulatory submission materials for completeness and compliance.
• Develop study-specific audit plans and coordinate responses; support inspections.

Skills

GCP/GLP QA leadership

Interpersonal skills

Regulatory compliance knowledge

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

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 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.

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 Now?

We’re always looking for solution-oriented, critical thinkers.

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 $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.