【ジョンソン・エンド・ジョンソン株式会社】[MedTech] Quality & Regulatory Compliance, Compliance manager
仕事内容
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.
応募資格(必須経験など)
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).