GCP Auditor - Global R&D Audit

About the role

Amgen's R&D Quality Audit Team, part of the R&D Quality Group, is looking for a GCP Auditor to join its global remit across the company's portfolio in all stages of development and post-marketing. The role involves planning and taking part in global audits of clinical trial activities and may also support regulatory inspections of clinical sites and Amgen facilities. Up to 40% of the time may involve travel to international destinations.

Key responsibilities

• Plan, conduct and report routine and direct GCP compliance audits internationally
• Serve as lead auditor for complex GCP audits
• Identify and communicate compliance risks to R&D Quality management
• Host and/or take part in regulatory authority inspections
• Contribute to or lead R&D Quality process improvement initiatives
• Author and contribute to R&D Quality cross-functional controlled documents

Required profile

• Doctorate degree, or Master's degree with 2 years of experience in a scientific discipline, medical sciences or pharmacy, or Bachelor's degree with 4 years of such experience, or Associate's degree with 8 years, or high school diploma / GED with 10 years
• Preferred: postgraduate qualification, experience in process improvement initiatives, and extensive experience conducting international GCP audits or acting as a regulatory authority inspector
• Excellent written and verbal communication skills

Required skills

• Data mining, manipulation and data analytics (advantageous)
• GCP compliance auditing

What we offer

• Annual salary range of $104,725 to $141,687 in the U.S. (excluding Puerto Rico), varying with skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans and flexible work models where possible