Head of QA Operations

YOUR TASKS AND RESPONSIBILITIES

Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives
To provide assistance to develop and implement quality systems as well as redesign through proven continuous improvement program to safeguard the SC Shiga and WJDC’s licenses to operate as well as ensure compliance with state-of-the-art standards, current GMP regulations and Bayer CMS requirements.
To make batch disposition and release decision as a Qualified Release Person of SC Shiga and to lead release office function
To handle/ manage deviations and CAPAs as well as Risk Management properly in a timely manner
To conduct necessary procedures to acquire/ renew the official permissions/ approvals, and to manage various Audits and to maintain good relationship with relevant authorities
To execute Supplier Management properly to obtain high quality materials
To manage External Audits (Type B) as a Audit Program Manager and self-inspections
To manage necessary QA/QCactivities at WJDC
To be a contact person for the responsible foreign manufacturing sites

WHO ARE YOU

University degree or above
At least 7 years’ experience in pharmaceutical industry including several years of leadership position in the Quality Assurance environment
Excellent pharmaceutical know-how (process technology, production, general regulations e.g. GMP, GQP, regulatory inspections)
Experience in managing complexity on problem solving and trouble shooting
Must have solid experience in managing a team
Strong command of English (TOEIC 730 or above)
Fluent in Japanese
Strong leadership skills and flexibility to positively lead change
Good Project management skills and learning’s from participation in multi-department, Quality and site projects