Director, Quality Assurance – Clinical and Nonclinical Development

Position Overview

A growing biotechnology organization is seeking a Quality Assurance (QA) Director to serve as the primary QA expert across both clinical and nonclinical programs. This role will partner closely with Clinical Development, Nonclinical, and other cross-functional teams to build and maintain pragmatic, risk-based quality frameworks that support regulatory compliance and data integrity from early development through clinical execution. The ideal candidate brings hands-on experience in gene therapy or gene-editing modalities, strong judgment, and a collaborative approach to working with cross-functional partners.

This role is expected to be onsite 2–3 days per week in the Greater Boston area.

Quality Strategy & Governance

• Define and implement the clinical and nonclinical quality strategy, incorporating ICH E6(R3) and ICH M3(R2)/OECD principles from first-in-human studies through later-stage development.
• Establish and oversee systems and processes—including SOP development—to enhance the quality and compliance of clinical and nonclinical programs, supporting CRO-run GLP studies and internal non-GLP activities in the U.S. and internationally.
• Collaborate with Nonclinical, Clinical Operations, CMC, and Regulatory teams to make risk-balanced decisions that protect study participants and maintain program timelines.
• Maintain and evolve a phase-appropriate Quality Management System (QMS) for GCP, ensuring proportionate controls based on indication, development phase, and patient risk. Review deviation, CAPA, and change control records as needed.
• Ensure data capture, management, and analysis processes are fit-for-purpose, including audit trail reviews and software assurance suitable for 21 CFR Part 11/EU Annex 11 compliance.
• Lead or support QA audits and inspections of sites, vendors, and studies. Ensure appropriate documentation, follow-up, and CAPA closure. Contribute to authoring and revising SOPs, templates, and procedural documents related to GLP and GCP activities.

Nonclinical Study Oversight

• Ensure nonclinical study protocols are reviewed and approved on schedule, with deviations properly captured, evaluated, and reported.
• Implement systems to ensure that study report data are accurate, complete, and traceable—from ELN entries to raw data and animal subjects where applicable.
• Confirm bioanalytical method qualification and validation activities align with internal SOPs, ICH M10, and relevant global guidance. Review bioanalytical reporting for clarity, traceability, and data integrity.
• Serve as the QA liaison to CROs conducting GLP studies, overseeing compliance with 21 CFR Part 58 and OECD GLP requirements.

Clinical Study Oversight

• Lead implementation of ICH E6(R3) through quality-by-design approaches and integration of Critical-to-Quality (CtQ) factors into study planning, execution, and monitoring.
• Perform proportionate risk assessments and maintain Quality Tolerance Limits (QTLs) to support participant safety and data quality.
• Collaborate with CMC teams to ensure appropriate GMP standards are met for advanced therapy investigational products in accordance with study documents; support comparability assessments using manufacturing quality knowledge.
• Review essential study documents—including protocols, ICFs, monitoring plans, and related materials—to ensure regulatory and SOP compliance. Maintain all QA documentation within relevant QMS and TMF systems.
• Apply a risk-based oversight model that tailors monitoring, deviation handling, and data governance to identified risks; ensure timely communication and resolution of quality issues.
• Support vendor selection and qualification activities; manage audit schedules, establish Quality Agreements, and monitor vendor performance. Provide just-in-time training to teams and sites on product-specific GCP expectations.
• Investigate and escalate potential scientific misconduct or serious breaches, ensuring proper root-cause analysis, documentation, and regulatory reporting.
• Lead inspection readiness activities, including mock interviews, issue storyboarding, and remediation sprints.

Required Qualifications

• 10 years of GCP/Clinical Quality Assurance experience, including at least 5 years in cell and gene therapy; direct experience with gene-editing modalities is strongly preferred.
• Proven success as the primary QA lead for early-phase clinical and nonclinical programs.
• In-depth knowledge of ICH E6(R3), ICH M10, OECD GLP, and FDA/EMA expectations for ATMPs/CGTs; practical experience bridging GCP, GLP, and GMP.
• Strong decision-making skills under uncertainty and the ability to influence program-level tradeoffs while maintaining compliance.
• Hands-on experience leading audits (sites, CROs, specialty vendors, bioanalytical labs) and inspection readiness with successful outcomes.
• Excellent written and verbal communication skills, including concise reporting and effective executive-level summaries.
• Experience implementing RBQM methodologies, QTLs, and data-driven quality metrics in CGT studies.
• ASQ CQA or similar auditor certification.