; Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families. Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives. Our culture is grounded in our values: ;Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients. We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at ;www.kkna.kyowakirin.com. Summary of Job: The Associate Director, Quality Control will play a critical role in designing and executing the operational readiness program for star- up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. The Associate Director position will lead and enable the timely completion of key milestones for ensuring production targets are achieved. This role will initially involve working in a greenfield environment and will transition to lead the Lab operations throughout the GMP-ready, Tech Transfer, Analytical Method Transfer, and facility licensure activities for the manufacturing of late clinical and commercial products. Accountable to ensure compliance of the QC laboratory areas with current GxP Standards and with all applicable Global, Regional, and Site procedures within Kyowa Kirin’s Quality Management System. The role will serve as a primary delegate representing the Sr Director, Quality Site Head as required to ensure timely, effective, and compliant execution of operational activities per approved pl..
