Quality Compliance Senior 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 proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy, for all stages of products in the clinical development program. You will support global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

• Serve as a Good Clinical Practices (GCP) Subject Matter Expert, providing independent quality guidance for clinical trials
• Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits
• Manage quality events and regulatory inspections, and advise on responses, including root cause analysis and CAPA plans
• Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) to identify and mitigate trial risk
• Support monthly meetings with clinical program leaders to review quality and compliance risks, including deviations, trends, filing timelines, inspections, and cross-program risks
• Conduct new vendor qualifications in a risk-based manner
• Analyze data quality trends, address areas of weakness and gaps, implement and communicate key quality metrics
• Coordinate and support key technologies for data collection and measurement (e.g., biomarker usage and imaging methods)