Description
Amgen is hiring a Senior Director to lead its global GMP/GDP audit organization and predictive compliance intelligence capability. The role owns the audit strategy, execution, technical standards, supplier and contract-manufacturer audits, CAPA effectiveness, inspection readiness, and an enterprise risk view built from audit data, regulatory trends, supplier performance, deviations, complaints, recalls, and other quality signals. It also develops predictive models, dashboards, AI-enabled tools, auditor competency standards, and continuous-improvement measures, while partnering with regulatory reporting, inspection lifecycle management, and external affairs. The position requires a doctorate, master’s, or bachelor’s degree combined with the specified years of biologics manufacturing and regulatory compliance experience, plus at least five years of people-management or leadership experience.
