GCP Quality Compliance Manager

Job description

Career Category Quality 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 COMPLIANCE MANAGER LIVE: What you will do: In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program, including protocol development, database lock, and regulatory submissions/ approvals. You will operate within Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials. - Serve as the GCP quality SME, providing independent qualit...