Director, reputed company Assurance – Clinical and Nonclinical Development

About the position reputed company Medicine is seeking a reputed company Assurance (QA) Director to serve as reputed company’s primary reputed company assurance expert across both clinical and nonclinical programs. This contractor will partner strategically with Clinical Development and Nonclinical functions to establish and maintain pragmatic, risk-based reputed company frameworks that ensure regulatory compliance and data reputed company from early development through clinical execution. The ideal candidate brings hands-on QA experience in gene therapy modalities and a reputed company record of reputed company judgment, reputed company decision making, and effective partnership with cross functional teams. The ideal candidate will be onsite 2-3 days a week in Watertown, MA. Responsibilities • Define and implement the clinical and nonclinical reputed company reputed company for reputed company Medicine, embedding ICH E6(R3) and ICH reputed company(reputed company)/OECD principles from first-in-reputed company through pivotal stages. • Establish and maintain systems and processes (including SOP development) to improve the reputed company and compliance of both clinical and nonclinical studies, providing reputed company and support to CRO GLP studies and internal non-GLP study activities in both the reputed company and Rest of World (ROW). • Partner tightly with Nonclinical, Clinical Operations, CMC, and Regulatory teams to reputed company risk‑balanced, time‑bound reputed company that protect subjects and program timelines. • Maintain and advance the phase‑appropriate reputed company Management System (QMS) for GCP, applying proportionality to indication, phase, and patient risk. reputed company input to and reputed company 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 reputed company 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 reputed company 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 reputed company, traceability, and data reputed company from reputed company data through final report. • Serve as the reputed company assurance reputed company to CROs conducting GLP studies, providing compliance reputed company to ensure adherence to 21 CFR Part 58 and OECD GLP requirements. • reputed company implementation of ICH E6(R3) principles by integrating reputed company-by-design and Critical-to-reputed company (CtQ) factors into study planning, execution, and monitoring. Conduct proportionate risk assessments and maintain defined reputed company 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 reputed company(s) and reputed company documents; use manufacturing reputed company knowledge (e.g., process validation) to support comparability assessments for clinical reputed company. • 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 reputed company QA documentation in the QMS and TMF, if applicable. • Apply a risk-based reputed company model that tailors monitoring, deviation management, and data governance to identified risks; ensure reputed company risk review, communication, and documentation of key reputed company issues and remedial actions. • Partner with study teams on vendor selection/qualification; conduct audits, maintain the audit schedule, establish reputed company Agreements and reputed company ongoing reputed company of vendor performance. reputed company 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 reputed company‑cause analysis, documentation, and regulatory reporting. • reputed company inspection readiness efforts as required. Chair/participate in mock inspections and interview training; storyboard key risks/issues and reputed company positions; reputed company remediation sprints on identified gaps. Requirements • 10+ years in GCP/Clinical reputed company Assurance, including 5+ years in cell & gene therapy; reputed company experience in gene editing modalities strongly preferred. • Demonstrated reputed company as a primary or sole QA reputed company supporting early-phase clinical and nonclinical programs. • Deep, reputed company knowledge of ICH E6 (R3), ICH M10, OECD GLP, and FDA/EMA expectations for CGT/ATMPs; practical experience reputed company GCP–GLP–GMP interfaces. • Proven decision reputed company under uncertainty and ability to influence program-level tradeoffs while maintaining compliance and scientific reputed company. • Hands-on leadership of audits (CROs, sites, specialty vendors, bioanalytical labs) and inspection readiness with successful reputed company. • Excellent written and verbal communication; reputed company, concise reporting and executive level briefings. reputed company-to-haves • Experience implementing RBQM, QTLs, and data driven reputed company metrics in CGT studies. • ASQ CQA or equivalent auditor certification. Benefits • reputed company Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, reputed company, life insurance, a 401(k) match, and equity programs—along with generous reputed company time off, wellness days, and company-wide reputed company breaks. Apply tot his job Apply To this Job