Director, Quality Assurance – Clinical and Nonclinical Development

Role Summary

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.

Responsibilities

• 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‚Äëbalanced, time‚Äëbound decisions that protect subjects and program timelines.
• Maintain and advance the phase‚Äëappropriate 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

• 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.

Clinical Study Oversight

• Lead implementation of ICH E6(R3) principles by integrating quality-by-design and Critical-to-Quality (CtQ) factors into study planning, execution, and monitoring. Conduct proportionate risk assessments and maintain defined Quality Tolerance Limits (QTLs) as appropriate to ensure participant safety and data reliability.
• Partner with CMC teams as needed to ensure ATMP GMP standards are maintained in accordance with the trial protocol, pharmacy manual(s) and related documents; use manufacturing quality knowledge (e.g., process validation) to support comparability assessments for clinical impact.
• Review critical study documents (e.g. clinical protocols, ICFs, monitoring plans, and other essential documents) to ensure compliance with applicable regulations, SOPs, and GCP guidelines. Ensure the maintenance of all QA documentation in the QMS and TMF, if applicable.
• Apply a risk-based oversight model that tailors monitoring, deviation management, and data governance to identified risks; ensure timely risk review, communication, and documentation of key quality issues and remedial actions.
• Partner with study teams on vendor selection/qualification; conduct audits, maintain the audit schedule, establish Quality Agreements and provide ongoing oversight of vendor performance. Provide coaching and just-in-time training to study teams and sites on product-specific GCP expectations.
• Receive, investigate, and escalate reports of potential scientific misconduct or serious breaches, ensuring appropriate root‚Äëcause analysis, documentation, and regulatory reporting.
• Lead inspection readiness efforts as required. Chair/participate in mock inspections and interview training; storyboard key risks/issues and dossier positions; lead remediation sprints on identified gaps.

Required Qualifications

• 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‚ÄìGLP‚ÄìGMP 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.
• Excellent written and verbal communication; clear, concise reporting and executive level briefings.

Preferred Qualifications

• Experience implementing RBQM, QTLs, and data driven quality metrics in CGT studies.
• ASQ CQA or equivalent auditor certification.