Manager, Quality Assurance & Distribution

The Quality Assurance Manager will perform GQP duties related to the distribution and launch of pharmaceutical products under the Associate Director of Quality Operations (Hinseki). This role will work under the direction of the Associate Director to perform the implementation and will work with Regeneron global folks to execute of the Regeneron Quality Management System relating to good distribution practices (GDP) and product release.

There will be significant engagement and collaboration with Global IOPS (Industrial Operations and Product Supply) teams. In accordance with the GQP General Rules for Quality Assurance Operations, you may be asked to act as a substitute in the absence of Hinseki. Responsibilities will include, but are not limited to, the following :

GQP & GMP Quality Assurance

• Quality Management : GQP QA Release, Inspection, Change Control, Deviation
• Creation and maintenance of Quality Agreement for Supplier
• Correspondence of the quality complaint, execute the quality improvement program
• Document Control and management of Global SOPs and related documents
• Correspondence with PMDA and Tokyo Metropolitan office (including Inspection)
• Investigate causes of quality defects and follow up on CAPAs
• Training for QA members and GQP self-Inspection
• Introduction and maintenance of Quality Systems (Document Management system) including CSV and ER / ES GQP / GMP（SOP）
• Others quality assurance related tasks

Requirements