R&D Compliance Sr. Manager
Amgen
Hong Kong, HK
2天前
  • Oversee and support compliance activities for clinical trials.
  • Provide compliance leadership and direct support for Amgen’s R&D business interests in the region (including business partners)
  • Lead and oversee local regulatory inspections and response preparation.
  • Provide remote and if necessary direct support to prepare for inspections for Amgen and Amgen business partners as needed.
  • Implement the global R&D quality, compliance, audit and L&P strategy and Quality Management System within the region.
  • Provide expert regional input to the annual risk assessment for audit planning.
  • Conduct / participate in regional audits as required.
  • Provide expert advice on QA / compliance / quality management activities and trends within the region.
  • Provide leadership and direction for compliance matters and HA inspection related action for the region.
  • Contribute R&D compliance input into vendor evaluations and due diligence activities within the region.
  • Lead interaction with local regulatory authorities on key compliance issues when necessary.
  • Mentor / Supervise compliance staff
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