Inspection Readiness Manager

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 Quality team who supports Clinical Program Operations by providing inspection readiness, Trial Master File, and clinical trial risk management expertise to ensure compliance with ICH GCP. Through these activities, the team helps protect trial participant rights, safety, and well-being while ensuring the integrity, quality, and credibility of clinical trial data.


• 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
  
  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.
  
  As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
• 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