Japan Quality Director

• Implement and maintain the Local Quality Management System (QMS)
• Oversee quality control for pharmaceutical products, ensuring compliance with GMP/GDP standards
• Manage deviations, CAPAs, complaints, and change control processes
• Lead supplier management, including qualification and selection of new vendors
• Represent the company with health authorities and other external stakeholders
• Collaborate with global quality teams, ensuring consistent application of quality standards
• Manage and develop a team of quality assurance professionals
• Lead internal audits and inspections, ensuring regulatory compliance
• Manage product recalls and field actions, collaborating with various teams and stakeholders

• Bachelor's degree in pharmacy, life sciences, or a related field
• Minimum 10 years of experience in the pharmaceutical industry, with at least 7 years in Quality Management Systems
• Expert knowledge of GMP, GDP, and Japanese pharmaceutical regulations
• Proven experience leading and managing a team of quality assurance professionals
• Strong understanding of quality risk management principles and techniques
• Excellent communication and collaboration skills, including fluency in Japanese and English
• Proven ability to interact effectively with health authorities and external partners
• Strong leadership skills with the ability to build consensus and drive results
• Experience with SAP systems is preferred
• Experience in product recall and field action management

Experience with SAP systems is preferred

• Health insurance
• Employee pension insurance
• Unemployment insurance
• Weekends and public holidays off