Director, Quality Assurance – Clinical and Nonclinical Development

Director, Quality Assurance – Clinical and Nonclinical Development

Watertown, MA

Company Overview:

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.

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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.

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

• 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.

• Ensure nonclinical study protocols are reviewed and approved on time, and that deviations from approved protocols are properly documented, evaluated, and reported. Implement systems and workflows to ensure that data in study reports are accurate, complete, and traceable through the ELN to raw data and animal subjects where applicable.
• Confirm that bioanalytical method qualification and validation studies are conducted in accordance with internal SOPs, ICH M10, and other applicable regulatory guidance. Review bioanalytical method reports for clarity, traceability, and data integrity from source data through final report.
• Serve as the quality assurance liaison to CROs conducting GLP studies, providing compliance oversight to ensure adherence to 21 CFR Part 58 and OECD GLP requirements.