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In this vital role within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities.
Job Responsibility:
Plan, conduct and report routine and directed GCP compliance audits internationally
Serve as a lead auditor for complex GCP audits
Identify and communicate compliance risks to R&D Quality management
Host and/or play a role in regulatory authority inspections
Contribute to or lead R&D Quality process improvement initiatives
Author and contribute to the development of R&D Quality cross functional controlled documents
Requirements:
Degree educated
Proven and extensive international auditing experience in GCP
Experience of data mining, manipulation and data analytics would be advantageous
Excellent written and verbal communication skills
Nice to have:
Experience of data mining, manipulation and data analytics would be advantageous
What we offer:
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
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