.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.Senior Manager, Therapeutic Area QualityWhat you will doLet's do this! Let's change the world! In this vital role you will report to the Therapeutic Area Quality Lead - Clinical & Research Quality (CRQ). The Senior Manager, Clinical Quality provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program.Each Senior Manager, Clinical Quality will support end to end quality oversight within one of four Therapeutic Areas (TAs): Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars. Each Senior Manager, Clinical Quality is responsible for supporting a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).You will play a vital role by developing deep knowledge of the clinical trials you support and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.ResponsibilitiesServe as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current standard process.Provide quality oversight for Amgen programs for all stages of products in clinical development.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/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights.Support monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs.Support response generation for audit findings and self-reported deviations.Support the establishment of regional expertise to ensure quality and compliance to local regulations.Conduct new vendor qualifications/evaluations in a risk-based manner