GCP Senior Auditor

Amgen's Global R&D audit team are engaging, motivated and highly respected experts in GCP, PV and GLP with proven industry, research and regulatory agency experience. This is an exciting opportunity for an experienced senior-level auditor to work with expert multi-disciplined audit teams across global locations and lead global GCP audits for clinical trials that includes vendors, affiliate offices, internal processes and pharmacovigilance activities.

Key responsibilities include:

• Planning, conducting and reporting on clinical trial and PV compliance audits.
• Following-up on corrective actions through resolution.
• Identifying and communicating compliance risks to QA and R&D management.
• Serving as a lead auditor for complex GCP and PV audits.
• Hosting and supporting regulatory authority inspections.
• Contributing to and leading QA process improvement initiatives.
• Authoring and contributing to the development of QA cross functional controlled documents.

Basic qualifications:

Doctorate degree and 2 years of related audit experience

OR

Master's degree and 6 years of related audit experience

OR

Bachelor's degree and 8 years of related audit experience

OR

Associates degree and 10 years of related audit experience

OR

High school diploma / GED and 12 years of related audit experience

Preferred qualifications:

• Masters' degree
• PV auditing experience
• Experience supporting regulatory authority inspections
• Participation in process improvement initiatives
• Extensive international auditing experience in GCP or as regulatory authority inspector

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.