Quality Operations Lead

Lead Consulting Group Tokyo, Japan

Posted on
Jun 1, 2021
Job type
Career level
Mid career
Job performance: Views: 4436 Applications: 0 Bookmarks: 0

Job Description

Quality Operations Lead

This position is critical to ensure sustainable compliance of biological and vaccine products, processes, and systems with our Company’s requirements and regulatory requirements.

He/she will perform quality oversight on biological and vaccine testing and packaging operations.

  • Batch record review and Release biological and vaccine products
  • Preparation and review of documentation related to biologics and vaccine operations related to external testing facilities
  •  Perform and review investigations related to analytical testing and packaging quality issues
  •  Perform and review corrective and preventive actions (CAPA), change control, etc
  • Perform improvement activities at biological and vaccine operations in quality
  • Be a counterpart for site quality with local/global manufacturing sites

Skills (include specific skill levels required to apply our Company's Leadership Principles)

  • Degree in Life Sciences, Pharmacology, or Science.
  • Minimum of 3 years experience in the regulated pharmaceutical environment; preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
  • Knowledge of biochemistry, testing knowledge on biological products
  • Knowledgeable of Industry Best Practices for quality and compliance-related topics.
  • Strong collaboration and cross-functional leadership skills to drive continuous improvements
  • Preferably have project management skills.
  • Preferable to have English language skills.

operations, process improvement, Quality Control
Education level
Bachelor's Degree
Japanese Level
English Level
Business Level
Annual Income
¥6M - 10M


105-0021 Tokyo, Japan

Lead Consulting Group


Tokyo, Japan

About Us

Lead Consulting Group is an executive recruitment consultancy company based in Japan.

We work closely with multinationals, midsize to small companies, governments, and educational institutions in the areas of human capital management and related services.

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