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About the Role
Amgen's shared mission to serve patients drives all that we do, making us one of the world's leading biotechnology companies. We are global collaborators researching, manufacturing, and delivering better products to over 10 million patients worldwide.
Responsibilities
- Lead GCP and IVDR Inspection Readiness and Preparation activities across Amgen’s clinical portfolio.
- Drive inspection readiness strategies and oversee site inspection preparation projects.
- Partner cross-functionally to strengthen operational quality, support successful regulatory inspections, and promote continuous improvement.
- 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.
Requirements
- 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
Skills
- GCP
- IVDR
- Inspection Readiness
- Regulatory Inspections
- Operational Quality
- Continuous Improvement
- Risk Management
- SharePoint
Location
- Cambridge
- Uxbridge
Work Type
- Flexible from home
- Regular office work
Experience Level
- Experienced professional
Education Level
- Degree educated
Benefits
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
About the Company
- Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
- A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Equal Opportunity
- Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
- Please contact us to request an accommodation.