Tokyo, Tokyo ロバート・ウォルターズ・ジャパン(株)

A leading pharmaceutical company is seeking a Head of Commercial Vaccine Quality. The selected candidate will lead the overall quality strategy, systems, and compliance for vaccines across Japan.

Responsibilities:

  • Lead and enhance the quality management system (QMS) for commercial vaccine operations in compliance with GMP, GDP, and GLP standards
  • Align quality strategies and initiatives with cross-site quality teams to ensure consistency and collaboration
  • Oversee vaccine quality performance, KPI monitoring, and continuous improvement programs
  • Manage quality control testing, sampling, and quality oversight for outsourced testing and validation activities
  • Prepare for and lead internal audits, regulatory inspections, and third-party assessments
  • Develop, train, and mentor quality teams to foster a strong quality culture and ensure operational excellence

Requirements:

  • Bachelor's degree or above in engineering
  • 12-15 years of experience in Quality in a GMP environment in the pharmaceutical industry
  • More than 5 years of QA leadership experience
  • Understanding of good manufacturing practices in Japan its various guidelines as well as international standards
  • Familiarity with state-of-the-art processes and systems related to production as well as quality control of the products (Digital/Automation concepts)
  • Fluent level written and verbal English and Japanese

Benefits:

  • Commutation, Housing, Overtime Work, etc.
  • Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity

Leave, Childcare Leave, Family Nursing Leave

  • Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program,

■ 語学力

英語のレベル: ビジネス会話

日本語のレベル: ビジネス会話



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