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.