Director of Quality Assurance

We are seeking a highly motivated and experienced Quality Assurance professional. The successful candidate will lead quality oversight for early phase clinical operations, manufacturing, and clinical supply of an autologous CAR T cell product, ensuring GMP and GCP compliance. This role will support the development, implementation, and maintenance of a phase-appropriate Quality Management System, with a strong emphasis on external vendor oversight, including GMP batch disposition and Clinical Data Oversight, and IND support for first-in-human studies. This position will provide both the strategic oversight of our quality vision and the hands‑on execution of daily QA activities. This is a full time position based in Seattle, Washington. Responsibilities: Provide end-to-end quality oversight of manufacturing, including drug substance and drug product activities conducted at external CDMOs. Ensure GMP readiness for clinical supply, including batch record review, deviation management and lot release. Partner with CMC and CDMOs to support tech transfer, manufacturing campaigns, and release testing for clinical material. Establish and execute clinical supply quality strategy, ensuring compliance of stability programs, reference standards, and comparability assessments as applicable. Partner with Clinical Operations and CROs to ensure early phase GCP compliance, including site audits, trial master file reviews, and investigator compliance. Implement and maintain a phase-appropriate QMS to support GXP compliance, including SOP development and maintenance, document control, deviation and CAPA systems, change control, and training programs. Lead qualification, onboarding, and ongoing oversight of third-party vendors and contract organizations (CROs, CDMOs) through audits, quality agreements, and performance monitoring. Provide quality oversight for IND-enabling studies, including analytical method validation, bioanalytical testing, toxicology, and study reports. Ensure compliance with FDA and ICH regulations applicable to IND submissions, including data integrity and documentation standards. Collaborate cross-functionally with CMC, Clinical Operations, Regulatory, Nonclinical, and Program teams to ensure quality is integrated into all processes. Provide support for any quality-related responses to regulatory agencies. Serve as the quality subject matter expert during the IND submission process. Qualifications: Bachelor’s or advanced degree in life sciences or a related discipline. 12+ years of experience in biopharmaceutical industry, preferably with GMP roles, including direct experience working in QA. QA or QC experience specific to Cell and Gene Therapy Products. Strong knowledge of FDA and ICH guidelines. Experience with CRO/CDMO oversight, including vendor audits, qualification, and management. Familiarity with electronic quality systems and tools for document management. Prior experience supporting IND submissions and agency responses is highly desirable. Prior experience building a quality system from the ground up is highly desirable. Experience working in venture-backed startups or early-stage biotech companies is a plus. Excellent interpersonal, communication, and organizational skills. Comfortable in a hands‑on, roll‑up‑your‑sleeves startup environment. $185,000 - $215,000 R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. #J-18808-Ljbffr