Senior Manager, Quality Compliance Lead - China

About the role

Amgen is looking for a Quality Compliance Lead, Sr Manager to report to the China Quality Compliance, Associate Director within Clinical & Research Quality (CRQ). The role provides end-to-end quality oversight for clinical development programs in China, covering assigned clinical trials, local procedures and suppliers and vendors, and implements a risk-based quality strategy across the full trial lifecycle.

Key responsibilities

• Review clinical trial protocols, simplify them, apply lessons learned and identify critical data and processes
• Provide quality oversight and risk assessment for each trial, including country-specific risks, to protect patient safety, welfare and rights
• Develop and implement regionally tailored Quality Plans and establish country-level expertise on local regulations
• Liaise with Clinical Quality Therapeutic Leads on data integrity, including biomarkers and imaging methods
• Collaborate on TA and local quality assurance plans, including audit plans and execution of investigator site, affiliate and study-level audits
• Support issue management (deviations, CAPAs, serious breaches, privacy issues), inspection readiness and audit management
• Prepare, analyse and share compliance metrics and trends with stakeholders and leadership, and recommend improvements
• Explore proactive quality methods such as risk-based approaches using AI, NLP and advanced data analytics
• Review local regulations, contribute to local and global SOPs and clarify their application in China

Required profile

• Bachelor's degree in an appropriate discipline or equivalent (e.g. biomedical science, nursing)
• Minimum 7 years in the pharmaceutical industry with in-depth knowledge of ICH GCP
• 4+ years in quality management, quality assurance or related fields, with risk-based quality and quality by design as a core responsibility
• Experience overseeing and implementing Quality Management Systems, including electronic QMS such as Veeva or Trackwise
• People leadership and mentoring expertise
• Ability to explain technical concepts in spoken and written English and Mandarin
• Local travel estimated at 20%; overseas travel may apply

Required skills

• Thorough understanding of clinical R&D activities and China, regional and global regulations
• Knowledge of regulatory submission and inspection management procedures
• Quality oversight of clinical trials, including protocol development, execution and submissions
• Strong analytical, critical thinking and decision-making abilities