GCP Auditor - Global R&D Audit

Amgen Inc

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.

Responsibilities

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

Requirements

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

Apply

Vacancy posted a month ago

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