QMS manager/ Biopharma (Tokyo)

Posté 08 févr. 2024

Tokyo, Tokyo - Japan

Demander un identifiant 270806


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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


  • 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



  • 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

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