Tokyo,14.0M ～ 18.0M

-Reports to Japan Portfolio Project Head are a Member of the Global Project Team to ensure understanding & alignment of the global vaccine development strategy and priorities.

-Works in collaboration with all the Global Project Team members & global functions to develop the Japan project strategy and timelines.

-Ensures integration of the Japan activities across all local Japan functions required to meet the Japan project objectives

-Sets up and leads the Japan Team to drive the execution of the Japan activities

-Leads the Japan team in assessing local project risks, developing risk management /mitigation plans, gaining consensus and support for implementing

-Financial acumen and visibility to project budget

-Ensures that Global team understands and integrates the Japan needs and specificities.

-Ensure effective communication and alliance management with third parties including partner companies, academic groups and joint ventures

-Maintain mechanisms to capture and share knowledge, leverage learning and implement improvements within the project team

Tokyo,8.0M ～ 12.0M

Design and Deliver Training Programs: Develop and implement effective training programs to enhance employee skills and performance.
Talent Acquisition: Manage the end-to-end recruitment process, from sourcing candidates to onboarding new hires.
Performance Management: Support the development and implementation of performance management systems to ensure continuous employee growth.
Employee Engagement: Foster a culture of continuous learning and development through various engagement initiatives.
Data Analysis and Reporting: Analyze training and recruitment data to measure effectiveness and make data-driven decisions.

Tokyo,14.0M ～ 18.0M

Manage Quality Information Management/Quality system group which is responsible for following with a view to total optimization rather than limited optimization.

In addition, promote people growth by supporting OJT activity of group members. Act as Quality responsible for Medical Device in J-QMS ordinance.

?Management of the task of Quality Information Management compliance to PMD-ACT, GQP/QMS regulation and company Quality directives.
-Maintaining GQP/QMS system as MAH
-Managing manufacturers of medical devices

?Management of Product Technical Complaint (PTC), Quality Information of responsible products released to the market.
-Handling PTC from receipt of complaint to reply to customers within PTC cycle time.
-Monitoring and analysis of PTC trend to detect any quality risks in a timely manner.
-Reporting PTC to concerned site / functions via defined platform
-Sharing the quality information with related functions, which can be a critical issue
-Supervising the activity of outsourced companies

?Management of the quality risk of the products released onto the market.
-Analysis of the root cause and confirmation of CAPA regarding PTC of manufacturing process-related or product related
-Analysis of the quality risk based on PTC and report to the management, and share the info on the related functions as appropriate
-Proposal of countermeasure to reduce the quality risk based on PTC
-Support to the new product development or launch in Japan with technical knowledge and feedback from the market

?Management of response to customers about PTC and improvement requests
-Arrangement of proper investigation and clarification of investigation results obtained from investigation site, if needed
-Participating in the Defect Evaluation Committee for reporting to HA
-Management of the effectiveness of the activity of outsourced company

?Management of defect reporting of MD and combination products in corporation with PSPV

?Act as support function of MSG (Soukatsu)
-Coordinate meetings of which MSG is the owner, create and store the meeting minutes.
-Create/revise/obsolete/storage of the SOP and related documents
-Plan/implement/document the training

?Quality system maintenance in accordance with global procedure
-Implementation of country quality review
-Coordinate Quality Audit conducted by global organization
-Coordinate regulatory inspection collaborating with related department
-Activity for audit/inspection preparation (Audit/inspection Readiness)
-Third Party management
-Management of global electronical Quality system as a representative of local market.
-Implement/coordinate Self inspection