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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