**
Amgen Inc. is seeking a Quality Compliance Manager for its operations in Japan, responsible for implementing risk-based quality assurance strategies in clinical development. The ideal candidate will have a strong background in quality management within the pharmaceutical industry, with specific experience in quality oversight and compliance.
**
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 communicate effectively in a global, cross-functional environment.
Matching Summary
Match Score: 75
**
Amgen Inc. is seeking a Quality Compliance Manager for its operations in Japan, responsible for implementing risk-based quality assurance strategies in clinical development. The ideal candidate will have a strong background in quality management within the pharmaceutical industry, with specific experience in quality oversight and compliance.
**
Skills & Requirements
Must-have
Risk-based quality strategy implementation
ICH GCP and PMDA regulatory knowledge
Clinical trial protocol review and oversight
Veeva or TrackWise QMS experience
Audit execution and inspection readiness
Nice-to-have
AI and Natural Language Processing methods
FDA and EMA inspection support experience
Strong business writing and communication skills
Cross-functional stakeholder partnership building
Key Requirements
Bachelor's degree in Biomedical Science or Nursing
Minimum 5 years in pharmaceutical industry
2+ years in Quality Management or Quality Assurance