Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

About the role

Amgen is looking for a Senior Director to lead its global GMP/GDP audit organization and its predictive compliance intelligence capability. The role is the single accountable leader of an integrated enterprise function combining independent audit assurance, operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance and internal quality signals. It moves the organization beyond retrospective identification of deficiencies toward earlier detection, prioritization and prevention of regulatory and quality risks.

Key responsibilities

• Set the strategic direction, operating model, technical standards and multiyear roadmap for the audit and intelligence capabilities.
• Lead the global risk-based GMP/GDP audit strategy and master audit schedule, covering manufacturing sites, programs, quality systems, suppliers, contract manufacturers, laboratories and distributors.
• Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation and closure.
• Build the predictive compliance intelligence capability, including data strategy, analytical methods, technology roadmap, governance, talent model and performance measures.
• Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints and recalls into a consolidated enterprise risk view.
• Develop predictive models, dashboards, early-warning indicators and risk scenarios; identify systemic risks and recurring failure mechanisms.
• Lead the technical capability strategy for auditors, including competency requirements, qualification standards and continuing education.
• Oversee AI-enabled audit and compliance intelligence tools, ensuring they support rather than replace human judgment and audit independence.
• Partner with Regulatory Reporting and Inspection Readiness, Inspection Lifecycle Management and External Affairs on inspection readiness, mock inspections and regulatory trend analysis.

Required profile

• One of: doctorate with 5 years of biologics manufacturing and regulatory compliance experience, master's with 9 years, or bachelor's with 11 years.
• At least 5 years of direct people management and/or leadership experience leading teams, projects or programs.
• Experience in biologics manufacturing and regulatory compliance.