Director, Quality Assurance Clinical and Nonclinical Development

Director, Quality Assurance Clinical and Nonclinical Development

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging 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.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus : hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.

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 contractor will partner strategically with Clinical 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.

The ideal candidate will be onsite 2-3 days a week in Watertown, MA.

Quality Strategy & Governance

• Define and implement 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.
• Establish and maintain systems and processes (including SOP development) 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 (ROW).
• Partner tightly with Nonclinical, Clinical Operations, CMC, and Regulatory teams to make risk-balanced, time-bound decisions that protect subjects and program timelines.
• Maintain and advance the phase-appropriate Quality Management System (QMS) for GCP, applying proportionality to indication, phase, and patient risk. Provide input to and perform reviews of Deviation, CAPA, and Change Management records.
• Ensure data capture, management and analysis is fit for purpose, including audit trail reviews and software assurance approaches to satisfy 21 CFR Part 11 / EU Annex 11 compliance requirements.
• Support or lead QA audits and inspections of clinical and nonclinical sites, vendors, and studies, ensuring appropriate follow-up and CAPA closure. Contribute to the authoring, review, and revision of SOPs, templates, and procedural documents related to GLP and GCP activities.

Nonclinical Study Oversight

Clinical Study Oversight

Required Qualifications

Preferred Qualifications