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Site Quality Head, Global Vaccine Business Unit - Japan  

Company managed [?] Still accepting applications

Posted on : 19 September 2017

Project Description

【Objective and Accountabilities】

1.Effectively manage the Quality Management System that supports Phase I-III CMC activities for Takeda Japan Vaccine Business Unit.

2.Effectively lead and manage the QA team that supports CMC activities associated with Takeda Japan vaccine programs.  This includes QA oversight of all manufacturing and Quality Control testing laboratories, both internal and external (contracted).

3.Effectively support and collaborate with global vaccines cross-functional leadership and teams in support of Takeda Japan vaccine programs.

4.Independently provide oversight and support to R&D CMC groups with Takeda Japan.

5.Support or act as primary quality operations liaison with the Boards of Health to ensure consistency in global product quality and compliance communications and responses.

6.Manage execution of global product quality strategy and drive changes to support manufacturing operations or product transfers.

7.Lead efforts to continuously improve GMP compliance.


Takeda’s Vaccine Business 

https://www.takeda.co.jp/access/activity/research/


Hikari Plant e-brochure (Japanese) 

http://www.takeda.co.jp/company/files/hikariplant_jp.pdf


【Employee Benefits】

Allowances: Commutation, Housing, Overtime Work etc.

Working Hours: Headquaters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, Research Site (Kanagawa) 9:00-17:45

Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

Paid Leaves: Annual Paid Leave, Special Paid Leave, Refresh Leave, Maternity Leave, Childcare Leave, Family Nursing Leave, Philanthropy Leav

【Education, Experience and Skills】

•Bachelor’s degree or higher in a scientific discipline.

•Minimum 15 years within vaccines, pharmaceuticals, biologics or other related industries.

•Minimum 8 years in QA leadership

•Experience hosting regulatory, health authority or other related inspections.

•Experience leading multi-functional teams.

•Excellent communication skills, both oral and written.

•Proficient at English, both oral and written.

Advantage: GMP Audit, vaccine experience.


Schedule
Full-time