InspectionReadinessManager

## **Career Category** Clinical ## ## **Job Description** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. **INSPECTION READINESS MANAGER** **LIVE** **What you will do** In this vital role, you will lead GCP and IVDR Inspection Readiness and Preparation activities across Amgen’s clinical portfolio, including early-phase, late-phase, and observational studies. You will 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. * Lead GCP and IVDR site inspection readiness and preparation activities, ensuring consistent execution and successful inspection outcomes. * 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. **Be part of our team** You would be joining the Operational Quali