Quality Compliance Manager

at  Amgen

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.

In this vital role you will provide quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in non-clinical development, with the main focus of maintaining the integrity of Amgen’s research data. You will be covering both regulated and non-regulated research, including Good Laboratory Practice (GLP).

• Support GLP compliance oversight through cross-functional collaboration with functional areas and stakeholder groups within Research in alignment with standard practices
• Plan, conduct and report out on risk-based R&D audits. Review, negotiate and approve responses to R&D audit findings and provide oversight for compliance activities through to finding closure
• Manage deliverables and provide data and recommendations regarding the state of quality for processes, technology, laboratory and external vendor performance
• Support the establishment of regional expertise to ensure quality and compliance to local regulations as well as support research-specific data integrity, including technologies for data collection and measurement
• Support Research for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management, compliance related questions and critical issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)