QMS manager/ Biopharma (Tokyo)

Posted 08 Feb 2024

Tokyo, Tokyo - Japan

Req Id 270806

 

Work Your Magic with us!  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day.

ヘルスケア、ライフサイエンス、エレクトロニクスの分野における世界有数の企業です。サイエンスとテクノロジーへのあくなき探究から生まれる革新的な製品・サービスで人々の豊かな暮らしを創造します。

メルクグループジャパンについて、こちらをご参照ください。

 


Position: QMS Manager

Location: Tokyo

Department: HC-GM-QCQ Quality Japan

Report to: Head of Quality Japan

Direct report: 0

 

You Role

The Quality Manager with Distribution Activities is responsible to define the strategy for implementing a Quality Management System (QMS) at the subsidiary.

The Quality manager is accountable for the quality and GQP/GMP/GDP compliance of:

  • Act as process owner for the Training management and Document management for Japan and global organization, act as a local Quality Learning Coordinator (as applicable)
  • Manage the Training and Document activities including the implementation of an appropriate action plan, fostering a Quality Culture
  • Implementation and management of quality documents including review and approval of quality documents
  • Training of local personnel on locally implemented Quality systems
  • Local Quality activities and Quality systems in place, and ensure they are maintained
  • Lead the Community of Practice for Training and Document Management
  • Ensure that the Training and Document systems are implemented consistently, effectively, and timely through the company’s network
  • Provide a consolidated view of Document and Training, and report to Management through the periodic reviews and appropriate reports in place
  • Ensure the compliance and efficiency of the Quality Systems for the above-mentioned systems
  • Support and train the manufacturing sites and subsidiaries in the management of Document and Training systems whenever appropriate
  • Ensure reporting and escalation of identified risks
  • Identify trends, analyze and provide recommendations and action plans on how the Quality Standards, Systems or Products should be modified or improved​​​​​​​
  • Contribute to the continuous improvement and the implementation of the global standards and procedures for the key quality processes of quality management system, through a collaborative approach with sites, subsidiaries and global functions.
  • Contribute at various levels to different improvement projects, such as the future eQMS Local QA activities and quality systems in place, and maintained
  • Ensure corrective and preventive actions are defined in a timely manner, documented, tracked, and closed in order to improve continuously the quality of the quality processes.

Who you are

Education

  • Bdachelor above
  • Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine, Engineering or a related scientific discipline or other related field
  • Background in Medicinal product distribution

 

Job Specific Competencies & Skills / Work Experience

  • Preferrably >3 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations(must to have), Distribution Warehouse management(nice to have) or other related activities
  • Proven experience in the area of regulatory compliance (GMP/GDP/GQP) and/or quality assurance systems
  • Excellent understanding of quality management systems
  • Experience in owning one of quality management systems such as Training or Document mangement (priority), Risk Management, Deviation, Change Cotrol, Audit
  • Experience in working with multiple competing stakeholders and priorities
  • Ability to successfully manage multiple critical issues simultaneously
  • Good time and priority management skills
  • Ability to prioritize and work in a rapidly changing environment.
  • Willingness and enthusiasm to learn and share knowledge
  • Excellent negotiation and influencing skills, highly desiered but not essential
  • Continuous improvement mindset, attention to detail, organizational skills

 

Languages

  • Native level in Japanse. Fluent in spoken and written English

 

Additional Requirements

  • Ability to travel nationally and internationally (Not offten. 1 or 2 times per year only when needed)
  • Computer skills (Word, Excel, SharePoint, etc.)
  • Basic Project Management and related tools skills, highly desired but not essential

 

Additional Local Legislative/Country specific Requirements

  • GQP / GMP / QMS/GCP Ordinances from MHLW

 

Recruiting contact: Fang Liu



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
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メルクグループのタレントゾーンにご登録ください!メルクのポジションにすぐに応募予定のない方も登録可能です。

メルクグループと、メルクにおけるキャリアオポチュニティーについて、理解を深めるいい機会を是非ご活用ください!

Talent zone link: https://careers.vibrantm.com/global/en/jointalentcommunity

 


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