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. This role will partner strategically with Clinical Development and Nonclinical functions to establish and maintain pragmatic, risk-based quality frameworks that ensure regulatory compliance and data integrity from early development through clinical execution. The ideal candidate brings hands-on QA experience in gene therapy modalities and a track record of sound judgment, collaborative decision making, and effective partnership with cross-functional teams.
Key responsibilities include evolving and delivering the clinical and nonclinical quality strategy for Prime Medicine, embedding ICH E6(R3) and ICH M3(R2)/OECD principles from first-in-human through pivotal stages. The Director will establish and maintain systems and processes to improve the quality and compliance of both clinical and nonclinical studies, providing oversight and support to CRO GLP studies and internal non-GLP study activities in both the United States and Rest of World. Additionally, the role involves maintaining and advancing the phase-appropriate Quality Management System (QMS) for GCP, applying proportionality to indication, phase, and patient risk.
The position requires a minimum of 10 years in GCP/Clinical Quality Assurance, including at least 5 years in cell and gene therapy, with direct experience in gene editing modalities strongly preferred. Candidates should demonstrate success as a primary or sole QA lead supporting early-phase clinical and nonclinical programs, possess deep knowledge of ICH E6 (R3), ICH M10, OECD GLP, and FDA/EMA expectations for CGT/ATMPs, and have practical experience bridging GCP–GLP–GMP interfaces. Excellent written and verbal communication skills are essential.
The pay range reflects the full-time base salary range expected for this role at the time of posting, which is $207,000 to $253,000 USD. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The company leverages its proprietary Prime Editing platform, a versatile, precise, and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs, and cell types.