Quality Compliance Lead, Sr Manager
Amgen · Shanghai, China +2 more
QualityFull-timeCompany career page
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Role summary
Amgen seeks a Quality Compliance Lead to oversee quality assurance and risk management for clinical development programs across China. The role involves developing region-specific quality strategies, managing compliance with local regulations, and collaborating with cross-functional teams to ensure data integrity and patient safety throughout the clinical trial lifecycle.
What they're looking for
- Bachelor's degree in biomedical science, nursing, or equivalent discipline
- Minimum 7 years pharmaceutical industry experience with ICH GCP standards knowledge
- 4+ years quality management or quality assurance in pharma/biotech with risk-based focus
- Experience with electronic QMS platforms such as Veeva or Trackwise
- Deep knowledge of clinical R&D activities and China, global, and regional regulations
- Fluency in English and Mandarin, both written and spoken
- People leadership and mentoring expertise with strong analytical abilities
What you'll be doing
- Review clinical trial protocols and identify critical data, processes, and lessons learned for simplification
- Perform risk assessments for trials to ensure mitigation of risks to data integrity and patient safety
- Develop and implement region-specific quality plans aligned with local regulatory requirements
- Execute quality oversight activities including audits, inspections, deviations, and issue management
- Prepare compliance metrics and communicate trends to leadership with recommendations for improvement
Privacy & handoff
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