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Quality Compliance Manager

Amgen

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Location:
Taiwan, Taipei

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Quality Compliance Manager will lead the implementation of a customized, risk-based quality assurance strategy for clinical development programs in Taiwan. You will oversee the full clinical trial lifecycle—from protocol development to regulatory submissions—ensuring quality standards are upheld across all local trials and associated suppliers/vendors.

Job Responsibility:

  • Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
  • Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
  • Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
  • Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
  • Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
  • Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
  • Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
  • Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

Requirements:

  • Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
  • Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
  • 2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
  • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
  • Thorough understanding of Clinical R&D activities and Global/local Regulations
  • Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
  • Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
  • Excellent verbal and written communication skills, including strong business writing abilities and active listening
  • Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
  • Strong analytical, critical-thinking, and decision-making abilities
  • Capability to understand and articulate technical concepts and literature in spoken and written English/Mandarin
  • Travel required (estimated 20%)
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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