About this role
About the Role We are seeking a highly motivated Specialist for Japan to join Gilead's Quality team as part of Tech.Ops and collaborate with Commercial teams to support commercial operation in this exciting new area of cancer immunotherapy. This role will help implement, improve, and execute the Good Quality Practice for Kite Japan, managing the local QMS and ensuring compliance with local regulations and company requirements. What You'll Do
- Responsible for quality monitoring of importation of Cell Therapy Finished Products in Japan.
- Maintain and update local QMS/GQP to adhere to local regulation (e.g., PMDA).
- Provides QA oversight and approves deviations, change controls and product complaints investigations for the manufacture, packaging and shipping events impacting Cell Therapy Products for Japan when applicable.
- Provides information, guidance or reports to management when specific compliance issues arise.
- Oversee and interface with manufacturing sites (in Japan and overseas) to address and resolve performance issues and quality events.
- Maintain metrics related to Quality of Commercial Cell Therapy Product(s).
- Support inspection readiness plans and interact with regulatory authorities (PMDA, etc.) during inspections on Kite related matters.
- Lead or support product complaints, deviations, or recall/Field Corrective Actions (reporting to Japan health authorities (PMDA, etc.))
- Lead for affiliate Kite GMP self-inspections.
- Conduct and manage internal or external audits. What We're Looking For
- Experience in quality assurance and oversight of deviations, change controls, and product complaints investigations.
- Ability to maintain and update local QMS to comply with PMDA and local regulations.
- Experience coordinating with manufacturing sites in Japan and overseas and addressing quality events.
- Familiarity with inspection readiness and interactions with regulatory authorities (PMDA, etc.).
- Experience leading or supporting GMP inspections and internal/external audits.
- Knowledge of cell therapy products and relevant regulatory landscape is a plus.