Director, Quality Assurance – Clinical and Nonclinical Development

Prime Medicine is seeking a Quality Assurance (QA) Director to serve as the company’s primary quality assurance expert across both clinical and nonclinical programs.

Requirements

• 10+ years in GCP/Clinical Quality Assurance, including 5+ years in cell & gene therapy; direct experience in gene editing modalities strongly preferred.
• Demonstrated success as a primary or sole QA lead supporting early-phase clinical and nonclinical programs.
• Deep, current knowledge of ICH E6 (R3), ICH M10, OECD GLP, and FDA/EMA expectations for CGT/ATMPs; practical experience bridging GCP–GLP–GMP interfaces.
• Proven decision quality under uncertainty and ability to influence program-level tradeoffs while maintaining compliance and scientific integrity.
• Hands-on leadership of audits (CROs, sites, specialty vendors, bioanalytical labs) and inspection readiness with successful outcomes.

Benefits

• Medical, dental, vision, life insurance, a 401(k) match, and equity programs
• Generous paid time off
• Wellness days
• Company-wide recharge breaks