Executive Director, Research & Clinical Development QA

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: Importance of the Role

The Executive Director Research & Clinical Development Quality Assurance provides senior leadership and strategic oversight for Quality Assurance activities supporting nonclinical (GLP/GCLP) and clinical development (GCP) programs as part of Sareptas Corporate Quality organization.

This role is accountable for the effective execution of Quality Assurance responsibilities including auditing compliance oversight and inspection readiness across critical phases of development while maintaining appropriate independence from study execution teams. The Executive Director ensures Quality systems processes and controls are designed implemented and maintained in compliance with GLP GCP GCLP and applicable regulatory requirements (FDA OECD ICH).

Operating within the Corporate Quality Organization this role partners closely with Research Clinical Development Regulatory Affairs and external partners (CROs vendors investigator sites) to foster a strong culture of quality drive continuous improvement and maintain inspection readiness in support of global development programs and regulatory submissions.

The Opportunity to Make a Difference

The Opportunity to Make a Difference:

• Provide senior leadership and strategic oversight for Research & Clinical Development Quality Assurance activities within the Corporate Quality organization supporting nonclinical (GLP/GCLP) and clinical development (GCP) programs across the development lifecycle.
• Lead an independent QA organization responsible for auditing compliance oversight and inspection readiness while maintaining appropriate separation from study execution teams.
• Ensure Quality systems processes and controls are designed implemented and maintained in compliance with GLP GCP GCLP and applicable regulatory requirements (FDA OECD ICH).
• Oversee QA review and oversight of nonclinical and clinical documentation including protocols amendments study reports investigator brochures and data supporting regulatory submissions (e.g. INDs BLAs RFIs PMRs).
• Lead and oversee audit programs covering internal processes CROs vendors laboratories and investigator sites and ensure findings are effectively assessed trended and remediated through CAPAs.
• Partner closely with Research Clinical Development Regulatory Affairs and external partners to provide riskbased Quality guidance drive continuous improvement and maintain inspection readiness across global development programs.
• Oversee Quality Systems supporting development activities within Corporate Quality Organization including deviations CAPAs change control document management and training.
• Recruit develop mentor and lead QA managers and staff building a highperforming scalable and collaborative organization.

More about You

Education

• Bachelors degree in Biomedical Sciences Life Sciences or a related field; advanced degree preferred.

Experience

• 12 years of progressive experience in Pharmaceutical or Biotechnology Quality including significant leadership experience in a QA and the GxP environment.
• Hands on experience in QA and have led a team
• Hands-on experience with cGMP manufacturing operations and oversight of CMOs.
• Direct experience supporting regulatory inspections and interactions with health authorities (e.g. FDA).

Skills

• Strong working knowledge of cGMPs GLPs GCPs and applicable international Quality standards.
• Solid understanding of FDA GMP regulations guidance and compliance expectations.
• Proven ability to lead teams influence cross-functional partners and drive execution in complex environments.
• Demonstrated sound judgment problem-solving skills and attention to detail.
• Ability to balance operational execution with strategic thinking.
• Strong communication interpersonal and collaboration skills.
• Self-motivated results-oriented and adaptable in a fast-paced environment.

Travel: Willingness to travel up to 2025% as needed.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas 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 $256000 - $320000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.