Head Of Quality Information Management (W/ People Management)

Publication date 2025/06/25

Work Location , Expected Annual Income :

Tokyo,14.0M ～ 18.0M

About the Company :

Global European Pharmaceutical Company

Responsibilities :

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

Benefits :

Work Location: Tokyo, Japan
Working Style: Hybrid Work Model
Budget Range 13-17milion yen annual total.
Interview steps: 3
Health Insurance: Covered
Social Insurances: Covered
Paid Holidays: 12 upon 1st year of joining.
Hours: Core and Flex time.

Required Experience / Abilities / Skills :

-Experience with Pharmaceutical quality assurance management.
-Knowledgeable about Japan pharmaceutical regulations and changes.
-Native communication ability in Japanese.
-People management experience or leadership role.

Contact Information :

Kent Gu
JAC International, Healthcare Team
Email: k-gu@jac-international.jp

If you are interested in this position, please feel free to email for inquiry.

JOB ID : IJB2009221