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Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The Executive Director, GMP Quality Assurance will lead the company's internal GMP quality operations and compliance program, ensuring all cell therapy products manufactured and tested for clinical use meet FDA, EMA, and global health authority requirements.
This role owns quality systems governing GMP manufacturing, batch disposition, deviations, CAPA, change control, and inspection readiness. The Executive Director builds and leads the GMP QA operations organization, sets quality policy and standards, and drives a culture of quality and continuous improvement across the company. The position operates with significant independence, exercising broad judgment in interpreting regulations and resolving complex compliance issues, and reports to the VP of Quality.
Key responsibilities include: leading GMP QA operations (document control, training, material release); managing GMP compliance (deviations, investigations, CAPA, change control, complaint handling, annual product reviews); chairing recurring governance meetings (Material Review Board, Change Control Board); ensuring compliance with 21 CFR Parts 210/211 and ICH Q7/Q9/Q10; serving as primary quality lead for FDA and health authority inspections; preparing for Biologics License Application (BLA) including quality gap assessments and CMC documentation; partnering with Technical Operations and Regulatory Affairs on technology transfer and process validation; owning the GMP QA risk register; driving risk-based quality decision-making; building and leading the GMP QA team; establishing policies, procedures, and quality metrics; and championing a culture of quality and continuous improvement.
Required qualifications: 15+ years progressive GMP quality assurance experience in biologics, cell therapy, or pharmaceutical manufacturing, including 8+ years in senior quality leadership; Bachelor's degree in life sciences, chemistry, engineering, or related field (advanced degree or ASQ CQA/RAC certification preferred); deep working knowledge of GMP regulations and direct experience hosting FDA inspections; proven track record building GMP QA teams and quality systems in growing biotech; experience with cell therapy or advanced therapy medicinal products (ATMPs) strongly preferred; strong knowledge of batch disposition, deviation/CAPA management, change control, and annual product review processes; excellent leadership, communication, and cross-functional collaboration skills.
