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Quality

[MedTech] Quality & Regulatory Compliance, Compliance manager

  • 標題 [MedTech] Quality & Regulatory Compliance, Compliance manager
  • 功能 Quality
  • 子功能 Quality Systems
  • 類別 Manager, Quality Systems (PL7)
  • 位置 Chiyoda, Tokyo-To, Japan
  • 刊登日期
  • 參考 2406206178W
馬上申請
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描述

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.


資格

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).

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