Amgen
biotechnology
InspectionReadinessManager
“Inspection Readiness Manager at Amgen. Skills: Inspection readiness, Clinical quality, Regulatory compliance. Lead GCP and IVDR inspection readiness. Lead GCP and IVDR preparation activities”
What You'll Achieve.
Ensure consistent execution; Ensure successful inspection outcomes; Strengthen operational quality; Support successful regulatory inspections; Promote continuous improvement
Industry & Context.
Identify quality trends; Identify risks; Identify inspection learnings
What They're Looking For.
Must Have
Degree educated, Work experience in life sciences or medically related field, Biopharmaceutical clinical research experience, Experience of global clinical trial conduct, Experience driving process development, Experience leading process improvement
Nice to Have
Experience as an Inspection Manager, Experience as a Risk Manager, Mandarin language
What You'll Do.
Lead GCP and IVDR inspection readiness
Lead GCP and IVDR preparation activities
Drive inspection readiness strategies
Oversee site inspection preparation projects
Partner cross-functionally to strengthen operational quality
Support successful regulatory inspections
Promote continuous improvement
Manage inspection readiness tools
Manage inspection readiness systems
Manage inspection readiness materials
Manage regulatory inspection preparation processes
Identify quality trends
Identify inspection learnings
Implement effective solutions
Partner with Inspection Readiness Support Team
Advance inspection readiness initiatives
Serve as subject matter advisor
Support internal audit activities
Maintain inspection readiness SharePoint resources
Maintain inspection documentation repositories
Maintain access management
Support strategic activities
Support operational activities
Mentor student interns
Develop student interns
How You'll Work.
Team & Collaboration
Partner cross-functionally; Inspection Readiness Support Team
Process & Methodology
Process development, Process improvement
Applying for this Inspection Readiness Manager role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Amgen?
Real rants from real employees. Read before you apply.