Career Category

Job Description

• 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