Jobs

Head of RA/QA

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Published:   2020/07/28

Type

Full time

Salary

¥ 30,000,000

Description

Head of Quality Assurance & Regulatory Affairs (MAH)
This role will report to the Global Head of Quality & Regulatory
You are responsible for:

Quality and regulatory in Japan Market.

  • Leading 5 managers (directly reporting into this position), as well as large number of RA/QA Specialists
  • Responsible for successfully dealing with and managing relationships with regulatory agencies such as the Japan Govt/ Competent Authority.
  • Lead and manage all QA activities in the Japan market. This includes responsibilities for Post-Market Surveillance (PMS), the Quality Management System and dotted line for RA.
  • Has all the responsibility for the MAH activity under requirement of PMDA
  • Quality Management Systems oversight, including deployment, Auditing, managing Corrective & Preventive actions (CAPA) and for the promotion of quality awareness.
  • Continuously measure, analyze and improve the performance of quality related KPIs in order drive business performance.
  • Foster a positive employee relations environment by promoting open communication, engagement and development of team members. Promote a culture of inclusiveness, trust, flexibility and teamwork.
  • Ensure collaboration by participating in and leading cross functional, global and Regional process improvement initiatives as deemed necessary to support the QMS. Support new business initiatives from a QMS maintenance.
  • Capable of working as part of , or leading a multi-disciplined team.


Specific Skill Requirements For This Role Include

  • Bachelor Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline). Advanced degree preferred in technical or clinical field.
  • Management and strong leadership skills in a challenging working environment.
  • In depth knowledge of key requirements for Post Market Surveillance and experience interfacing with Japan regulatory bodies/health ministries.
  • Experience with managing product approval process in applicable markets and respective countries.
  • Must have strong knowledge of Japanese Regulations, awareness of ISO 13485, 9001, and 14971 (Risk management).
  • Ability to resolve complex issues in creative and effective ways and to introduce new
  • Strong interpersonal and communication skills at all levels in the organization

Requirements

  • Salary range is up to about ¥26M
  • Reason for hiring: the current/incumbent is going to retire this year.
  • 5 managers directly reporting into this position (Quality) and 1 manager (Regulatory Affairs) is dotted. The entire org is 60-70