[MedTech] Quality & Regulatory Compliance, Compliance manager

Description

SCOPE OF THE ROLE AND BASIC PURPOSE

・ Supervise Compliance group which enables JJKK continue to be compliant with Japanese regulations and J&J Quality Policies through the entire Quality Management System.

・ Development and continuous improvement of a quality management system that complies with Japanese regulations and standard requirements and takes into account the needs of internal stakeholders.

・ Accountable for Standard Operating Procedure (including but not limited to Document Control, Change Control, Internal Audit, Management Review)

・ Deliver value and process effectively to our customer and business by building partnership with stakeholders (internal and external).

・ Supervise budget, staffing, career planning, training and development and providing for a safe and pleasant working environment for Compliance group.

Qualifications

Experience and Skills:

Required:

• At least 5 years of experience in Quality Assurance or Quality System function within the regulated Medical Device or Pharmaceutical industry
• Talent development skill with deep insight for each staff and strong leadership for providing necessary training.
• Ability to encourage staffs for new changes and challenges.
• Ability to make a short/long term strategic objective.
• Having well-knowledges for Quality Management System, and relative regulations for Domestic and overseas.
• Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines.
• Ability to work both independently and in collaboration with others.
• Deliver opportunities to generate a lot of ideas for staffs, and proactive approach/uses own initiative appropriately.
• Logical thinking, decision making, problem-solving skills, positive thinking, and attitude to learn new things.
• Building partnership with stakeholders internally and externally.

Other:

• Native verbal and written communication skills in Japanese.
• English skill in business level.
• Experience in global/cross culture environment.

Education:

• Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).