Prime Medicine, Inc. · 1 month ago
Director, Quality Assurance – Clinical and Nonclinical Development
Watertown, MA
Full-time
Onsite
Director/Executive
$207K/yr - $253K/yr
10+ years expPrime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Quality Assurance Director will serve as the primary quality assurance expert, partnering with clinical and nonclinical functions to establish quality frameworks that ensure regulatory compliance and data integrity.
BiotechnologyGeneticsLife ScienceMedicalTherapeutics
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‑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
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‑cause 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
Qualification
Required
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
Excellent written and verbal communication; clear, concise reporting and executive level briefings
Preferred
Experience implementing RBQM, QTLs, and data driven quality metrics in CGT studies
ASQ CQA or equivalent auditor certification
Benefits
Medical
Dental
Vision
Life insurance
A 401(k) match
Equity programs
Generous paid time off
Wellness days
Company-wide recharge breaks
Company
Prime Medicine, Inc.
Prime Medicine was founded to bring the promise of gene editing to patients.
201-500 employees
H1B Sponsorship
Prime Medicine, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (12)
2023 (11)
2022 (5)
2021 (5)
Funding
Current Stage
Public CompanyTotal Funding
$558.15MKey Investors
Google VenturesCystic Fibrosis FoundationBristol-Myers Squibb
2025-08-01Post Ipo Equity· $4.95M
2025-07-30Post Ipo Equity· $144.2M
2025-07-16Post Ipo Equity· $24M
Leadership Team
Allan Reine
Chief Executive Officer and Board Member
Andrew Anzalone
Director, Head of Prime Editing Platform
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