Quality Assurance Sr. Manager/Director
Category | QC/QA (GMP, GQP, QMS, GVP) | Salary | 10 - 15 M¥ |
Work Type | Permanent | Date | 2012-02-12 |
Location | Tokyo | Ref.# | VDE 3133136 |
Overview
Market leader in niche area
Company Description
-Pharmaceutical company with a small operation including manufacturing in Japan
-Market leader in their niche area
Responsibilities
-Responsible for the implementation and management of the Quality System and its certification to MHLW, GMP and ISO standard
-Notifying MHLW of any manufacturing and analytical changes
-Handling of communications in the event of product recall
-Ability to conduct administration smoothly both internally and with regulatory agencies
-The position does not involve sales activities associated with the promotion of pharmaceutical products
-Primary interface to all local QA by the production sites and locally to domestic contractors/vendors
-Implement and execute an adequate monitoring -Collect, review, trend and prepare management reports for KPIs for production sites and contractors/vendors
-Collect, review, trend and prepare management reports for product complaints and MDR originated in Japan
-Support Regional Marketing and Sales plan
-Provide feedback to Corporate Headquarters involving new regional rules and regulations
-Lead the quality effort to identify key areas for quality improvement that reduce cost, non conformances (and rejects for Medical Devices)
-Conduct management review meetings, track progress of quality objectives and lead the internal audit program
Requirements
-Greater than 3 years experience in quality affairs administration (quality affairs experience outside the pharmaceutical industry, particularly in manufacturing and manufacturing administration, also acceptable)
-Good knowledge of the Pharmaceutical Affairs Law in Japan (2005 revision)
-Ability to communicate effectively in English with Corporate Headquarters functions and relay such communications to management and staff within the company
-Managerial experience
Preferred Experience
Preferred experience in medical devices and related quality affairs execution activities
Desired Traits
Effective experience in dealing with regulatory agencies on the metropolitan government level as well as on the prefectural level and ability to negotiate effectively with such agencies
Description of Benefits
Paid leave
Commute allowance
Social insurance
Holidays: Standard
Additional Notes
Quality Assurance Sr. Manager/Director