Manage and oversee QMS (Quality Management System) in PSJ to maintain MAH in Japan. Coordinate and deal with GVP/GPSP inspections by HA and internal/external audits, and lead the development of CAPA as needed. Collaborate with the team leader to guide and develop team members in line with the IPS vision. Ensure GVP and GPSP compliance, including the management and oversight of the deviation and CAPA process. Coordinate internally and with HA inspectors and internal auditors as a lead contact of PSJ during global PV audit of BMSKK and GVP or GPSP inspection by regulatory authorities. Oversees and advises on the plan for the creation and update of procedural documents, to meet internal company standards and GVP and GPSP regulations, in collaboration with Global Process Excellence team. Negotiate with vendors and the other pharmaceutical companies to make strategic PV/PMS agreements in collaboration with related local/global functions. Assist in maintaining BMSKK GVP and GPSP organizational structure documents as formal documents. Compile the monthly report of the Anseki and Choseki. Conduct self-inspection based on GVP or GPSP-SOPs and WIs. Lead the outsourcing strategy of GVP and GPSP operations in collaboration with stakeholders. Oversee the archival of local GVP and GPSP related documents stipulated in GVP/GPSP-SOP. Discuss effective and efficient method of safety communication with HCPs and patients at the time of EPPV with a function in PSJ that plans EPPV and the commercialization team that implements EPPV. Oversee the PSJ contributions to the Precautions section of the Japan package insert. In coordination with Global Training, lead the BMSKK training strategy and oversee the plan to ensure BMSKK colleagues are trained based on GVP and GPSP-SOPs and WIs. Elevate capabilities across PSJ on management of deviations, root cause analysis, CAPA. Foster a culture of integrity, quality, and compliance. University Bachelor of Science or Master of Science desirable. Pharmacist license desirable. Five (5) years pharmaceutical industry and GVP or GPSP operational experience. Knowledge of Pharmaceutical & Medical Device Act., Fair Competition Code (FCC), Promotion Code and related regulations, GVP/GPSP ministerial order. Knowledge on provision of Medical Information in Japanese industry. Basic knowledge on safety management for pharmaceuticals. Negotiation skill on issues with internal and external stakeholders Communication skills in Japanese English reading and writing skills Cross-functional collaboration skill Presentation skill