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
- 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