GCP Quality Auditor

Overview

As a GCP Quality Auditor at Amgen, you will lead and participate in global audits of clinical trial activities, supporting regulatory inspections when needed. You’ll identify compliance risks, contribute to process improvements, and help ensure quality across R&D. This role sits in a expert team with broad geographic scope, offering growth and cross-functional collaboration. You will impact patient access by upholding rigorous GCP standards and regulatory readiness.

Pay / Benefits

• vast opportunities for growth across the global organization
• diverse and inclusive community
• generous Total Rewards Plan (health, finance and wealth, work/life balance, career benefits)

Responsibilities

• Plan, conduct and report GCP compliance audits internationally
• Lead audits for complex GCP engagements
• Identify and communicate compliance risks to R&D Quality leadership
• Support regulatory authority inspections at sites and facilities
• Contribute to or lead process improvement initiatives in R&D Quality
• Author and contribute to cross-functional controlled documents

Key requirements

• Degree educated
• Proven and extensive international auditing experience in GCP
• Experience with data mining, data manipulation and data analytics would be advantageous
• Excellent written and verbal communication skills

• Excellent written and verbal communication
• Strong collaboration across global teams
• GCP auditing
• Data mining and data analytics (advantageous)

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