Japan Quality Director, Randstad

Japan Quality Director

Randstad

Location:

Japan, Tokyo

Category:

Pharmacy

Contract Type:

Not provided

Salary:

18000000.00 - 22000000.00 JPY / Year

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Job Description:

Lead quality assurance and compliance for a global biopharmaceutical leader in Japan – a dynamic and impactful role. As the Japan Quality Director, you will be the champion of quality assurance and compliance within the Japan market. You'll ensure adherence to all local regulations and global company standards, while acting as a key liaison between the Japanese subsidiary and global quality teams.

Job Responsibility:

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

Requirements:

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

Nice to have:

Experience with SAP systems is preferred

What we offer:

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

Additional Information:

Job Posted:

April 15, 2025

Expiration:

March 12, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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