Career Category

Job Description

Position: Title: GCP Auditor - Global R&D Audit

Team: Global R&D Audit

Preferred location: Cambridge or Uxbridge

The Company:

Amgen is one of the world’s largest independent biotechnology companies, with global revenue in excess of $20 billion and over 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, we have invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

Your Team:

You will be working as part of the Global R&D audit team who has remit for Amgen’s R&D audit programme across GCP, PV and GLP. The team consists of a group of engaging, motivated and highly respected experts in the GxPs, with many years of industry, research and regulatory agency experience.  You would work with expert auditors across global locations as well as with multi-disciplined audit teams.

Your Role:

This is an exciting opportunity for an experienced Auditor to join Amgen's Global Research and Development Audit team. It is a key position, in Amgen’s Quality Assurance (QA) group, with primary responsibility for planning and participating in global GCP audits.  The breadth of audits performed include audits of Amgen’s clinical trials initially with scope to move on to auditing vendors, Affiliate offices and internal processes.

Your key responsibilities include:

• Plan, conduct and report routine clinical trial compliance audits as part of an audit team.
• Support GCP vendor and internal audit process audit programme as required.
• Follow-up on corrective actions until resolution.
• Identify and communicate compliance risks to QA and R&D management.

Basic qualifications:

• Bachelor’s degree in a scientific discipline.
• Extensive auditing experienced in GCP with proven ability to conduct audits with limited supervision.

Preferred Qualifications:

• Postgraduate qualification.
• International auditing experience.
• Participation in process improvement initiatives.

Location:

Cambridge or Uxbridge

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme
 

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.