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Quality Compliance Associate Director

https://www.randstad.com Logo

Randstad

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Location:
Japan , Tokyo

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Contract Type:
Not provided

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Salary:

12000000.00 - 16000000.00 JPY / Year

Job Description:

Lead and grow a team, build cutting-edge quality systems, and develop your expertise in a dynamic global biopharmaceutical company. You will be a key leader in ensuring the highest standards of regulatory compliance and quality across multiple disciplines within the organization. You'll lead a team of quality professionals, collaborating closely with global counterparts to implement and improve quality assurance systems. You will drive change management initiatives and play a critical role in ensuring compliance with global and local GxP guidelines. This is a fantastic opportunity to develop your leadership and technical expertise within a leading global biopharma company.

Job Responsibility:

  • Lead the development and implementation of quality assurance systems and procedures
  • Manage and mentor a team of quality professionals
  • Collaborate with global teams on regulatory compliance and quality initiatives
  • Drive change management processes and ensure adherence to GxP guidelines
  • Develop and maintain quality agreements with contract manufacturing organizations (CMOs)
  • Manage and optimize the quality budget

Requirements:

  • Minimum of 5 years of experience in GQP/GMP in the pharmaceutical industry
  • Experience in drafting and negotiating Quality Agreements (QAGs) with CMOs
  • Proven experience in leading and mentoring teams
  • Strong understanding of Japanese and global pharmaceutical regulations
  • Expert knowledge of GQP/GMP principles and practices
  • Excellent communication and collaboration skills in both Japanese and English
  • Bachelor's degree in pharmacy or a related scientific field
  • Experience with biological products is highly preferred
  • Ability to work effectively in a dynamic and fast-paced environment
  • Strong leadership and decision-making skills

Nice to have:

Experience with biological products is highly preferred

What we offer:
  • 健康保険
  • 厚生年金保険
  • 雇用保険
  • 土曜日
  • 日曜日
  • 祝日

Additional Information:

Job Posted:
January 25, 2026

Expiration:
April 09, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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