Sr Mgr/Associate Director, GMP Quality Assurance

Reporting to the Sr. Director of GMP Quality Assurance, the Sr. Manager/Assoc. Director GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance. You will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substances, and Drug Products. Incumbent will continuously improve and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management. Essential Job Functions include planning and overseeing day-to-day GMP activities of the quality function, ensuring appropriate quality oversight of external Vendors, reviewing and approving Vendor GMP documentation and Quality Events, and participating in Kura GMP sub-teams as the Quality Representative. The role requires a BS/MS degree in a scientific discipline and 8+ years (Sr. Manager) or 10+ years (Associate Director) of experience in regulated pharmaceutical manufacturing with significant GMP/CMC QA experience. The candidate must have a working knowledge of clinical and commercial manufacturing and quality processes and possess strong communication and motivation skills.