GCP Auditor - Global R&D Audit

Amgen · Remote

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Role summary

Amgen seeks an experienced GCP auditor to plan and conduct global compliance audits of clinical trial activities across the R&D portfolio. The role involves leading complex audits, supporting regulatory inspections, and driving quality improvement initiatives with up to 40% international travel.

What they're looking for

Doctorate degree, or Master's degree with 2+ years scientific/medical/pharmacy experience
Bachelor's degree with 4+ years scientific/medical/pharmacy experience, or equivalent
Experience conducting international GCP audits or regulatory inspections
Excellent written and verbal communication skills
Knowledge of data analytics and process improvement methodologies

What you'll be doing

Plan, conduct, and report routine and targeted GCP compliance audits internationally
Serve as lead auditor for complex GCP audit activities
Identify and communicate compliance risks to R&D Quality management
Support regulatory authority inspections at clinical sites and facilities
Contribute to or lead R&D Quality process improvement and controlled document development

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