Lead GCP and IVDR Inspection Readiness and Preparation activities across Amgen’s clinical portfolio, including early-phase, late-phase, and observational studies
Drive inspection readiness strategies, oversee site inspection preparation projects, and partner cross-functionally to strengthen operational quality, support successful regulatory inspections, and promote continuous improvement across the organization
Manage inspection readiness tools, systems, materials, and regulatory inspection preparation processes
Drive continuous improvement initiatives by identifying quality trends, risks, and inspection learnings, and implementing effective solutions
Partner with the Inspection Readiness Support Team to advance study health, quality, and inspection readiness initiatives
Serve as a subject matter advisor on inspection readiness and support selected internal audit activities
Maintain inspection readiness SharePoint resources, inspection documentation repositories, and access management
Support the Inspection Readiness & Operational Quality Senior Manager in strategic and operational activities
Mentor and develop student interns

Degree educated
Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
Experience of, or oversight of global clinical trial conduct
Experience driving and leading process development and /or improvement
Experience as an Inspection, or Risk Manager is preferred
Mandarin language is preferred but not mandatory

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

Inspection Readiness Manager

Key skills