Remote GCP Quality Auditor: Lead Audits & Compliance

Amgen; Cambridge, Uxbridge; Hybrid; GBP 70,000 - 95,000; Full time

Job summary

Amgen in the UK seeks an experienced GCP Quality Auditor to plan, conduct and report international GCP audits within R&D. You will support regulatory inspections of clinical sites and Amgen facilities, identifying compliance risks and contributing to quality improvements across the portfolio.

The role offers flexibility to work from home with regular office work in Cambridge or Uxbridge, and up to 40% travel to international destinations.

Qualifications

• 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.

Responsibilities

• 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

Skills

data mining

data analytics

written communication

verbal communication

Education

Degree educated

Job description

Amgen in the UK seeks an experienced GCP Quality Auditor to plan, conduct and report international GCP audits within R&D. You will support regulatory inspections of clinical sites and Amgen facilities, identifying compliance risks and contributing to quality improvements across the portfolio.

The role offers flexibility to work from home with regular office work in Cambridge or Uxbridge, and up to 40% travel to international destinations.