Director, Quality Operations

Role: Director of Quality Operations overseeing GMP compliance and quality management for clinical-stage oncology therapeutics, including small molecules and biologics (ADC, radioligand therapies), supporting both clinical and commercial development phases. Responsibilities: lead quality oversight of manufacturing, packaging, validation, and technical documentation; manage vendor qualification, CAPA, deviations, and change controls; ensure regulatory inspection readiness and support regulatory submissions; drive continuous improvement and quality culture; oversee documentation and compliance activities. Requirements: minimum 10 years in GMP quality assurance within pharma/biotech, with experience managing outsourced manufacturing, inspections, and audit processes; strong knowledge of global GMP/GDP regulations; proven leadership in regulatory audits, CAPA, and risk management; experience with development to commercial stage programs, particularly in oncology modalities like ADCs. Preferred: experience with small molecules, biologics, ADCs, and radioligands; prior success in inspection management and regulatory interactions. High-Value: extensive GMP/QMS expertise, global inspection readiness, oversight of CMO/vendor performance, and strategic leadership in quality for oncology therapeutics. Work setup involves up to 20% travel; based in Washington State.