GCP Quality Auditor

Job description preview

From Amgen’s original posting

Career Category Compliance Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. GCP QUALITY AUDITOR LIVE What you will do In this vital role within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities. Key responsibilities include: • 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…