The position in Japan serves as the primary Quality contact, requiring expertise in GxPâs, GQP, and Quality Management Systems (QMS) within a global context. Responsibilities include implementing and overseeing local and Enterprise Quality Systems, ensuring compliance with regulations and standards, and supporting business objectives. Acting as a key commercial partner, the role collaborates with the General Manager and cross-functional teams for product launches and QMS changes. Additionally, the position leads the local Quality team, ensuring consistency and adherence to standards, and engages in Quality discussions with regulators such as the Tokyo Health Authority and PMDA.
Requirements
10+ years of hands-on QA/ Compliance and management experience in the Pharmaceutical industry
Registered Pharmacist is preferred (Soseki)
Extensive knowledge of Local and global requirements required for GXP compliance.
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