Quality Compliance Manager

Amgen Australia Pty Ltd

Tokyo, Japan
**
Risk-based quality strategy implementation
Ich gcp standards knowledge
Clinical trial protocol review
** Amgen Australia Pty Ltd is seeking a Quality Compliance Manager based in Tokyo, Japan, to oversee quality assurance strategies for clinical development programs. The ideal candidate will have extensive experience in quality management within the pharmaceutical industry, particularly in ICH GCP standards, and proficiency in both English and Japanese. **

Job Summary

  • This role provides proactive end-to-end quality oversight strategies for clinical development programs within Japan.
  • The Quality Compliance Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles across the full clinical trial lifecycle.
  • Candidates must possess business-level proficiency in both English and Japanese to effectively communicate in a global, cross-functional environment.

Matching Summary

Match Score: 75

** Amgen Australia Pty Ltd is seeking a Quality Compliance Manager based in Tokyo, Japan, to oversee quality assurance strategies for clinical development programs. The ideal candidate will have extensive experience in quality management within the pharmaceutical industry, particularly in ICH GCP standards, and proficiency in both English and Japanese. **

Skills & Requirements

Must-have

  • Risk-based quality strategy implementation
  • ICH GCP standards knowledge
  • Clinical trial protocol review
  • Quality Management System oversight
  • Veeva or TrackWise experience
  • Japan PMDA regulatory understanding

Nice-to-have

  • AI and NLP quality methodologies
  • FDA and EMA inspection support
  • Biomarker data integrity expertise
  • Cross-functional stakeholder collaboration
  • Advanced data analytics application

Key Requirements

  • Bachelor's degree in Biomedical Science or Nursing
  • Minimum 5 years pharmaceutical industry experience
  • 2+ years in Quality Management or Assurance
  • Experience with electronic QMS (Veeva/TrackWise)
  • Fluency in English and Japanese languages

Work Rights

Not specified

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