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

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence What you will do Let’s do this. Let’s change the world. The Senior Director is the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability. The role leads an integrated enterprise function combining independent audit assurance, deep Operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance, and internal quality signals. The Senior Director is accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program while building a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention. The role leads two fully integrated capabilities: Global GMP/GDP Audit, including internal audits of manufacturing sites, programs, and quality systems, and audits of suppliers, contract manufacturers, laboratories, distributors, and other regulated service providers. Predictive Compliance Intelligence, focused on identifying weak signals, forecasting compliance vulnerabilities, detecting systemic trends, and translating intelligence into audit priorities and broader risk-mitigation actions. The function is intended to move the organization beyond retrospective identification of deficiencies toward earlier detection, prioritization, and prevention of significant regulatory and quality risks. Key Responsibilities Serve as the single accountable leader for the global GMP/GDP audit organization and predictive compliance intelligence capability. Establish the strategic direction, operating model, technical standards, and multiyear roadmap for both capabilities. Lead the global risk-based GMP/GDP audit strategy and master audit schedule. Ensure the audit program maintains sufficient technical depth to evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities. Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure. Establish expectations for process-based, inspection-ready auditing that evaluates actual execution, system effectiveness, product impact, data integrity, and broader applicability. Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multi-site evaluation, or executive escalation. Build the predictive compliance intelligence capability, including its data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures. Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into a consolidated enterprise risk view. Develop predictive models, dashboards, early-warning indicators, and risk scenarios to guide audit priorities and proactive intervention. Identify systemic risks and recurring failure mechanisms across sites, suppliers, products, processes, and quality systems. Lead the technical capability strategy for auditors, including competency requirements, qualification standards, continuing education, and access to appropriate subject-matter expertise. Oversee AI-enabled audit and compliance intelligence tools. Ensure AI supports, but does not replace, qualified human judgment, accountable Quality decisions, audit independence, and objective evidence. Serve as a GMP/GDP advisor to the separate enterprise AI governance organization. Provide senior leadership with clear, actionable insight on emerging compliance risks and recommended interventions. Lead and develop a highly qualified, multidisciplinary global audit and compliance intelligence organization. Own the audit continuous-improvement roadmap and measures of audit effectiveness, not merely audit completion. Regulatory Compliance Collaboration The role will partner closely with: Regulatory Reporting and Inspection Readiness (RRIR) to apply audit and predictive intelligence to inspection readiness forums, pressure testing, mock inspections, inspection strategy, on-site inspection support, and response development for significant or multisite findings. Inspection Lifecycle Management (ILM) to integrate audit findings with inspection outcomes and lessons learned. ILM retains ownership of observation ratings, inspection scoring, and regulatory commitment tracking and closure. External Affairs to monitor emerging health-authority policy, enforcement priorities, and regulatory trends and translate them into audit, surveillance, and compliance priorities. Measures of Success The global audit program demonstrates increased technical depth, challenge, consistency, and inspection relevance. Predictive compliance intelligence is established as a credible and actionable enterprise capability. The function identifies meaningful risks that would not have been detected through the routine audit program alone. Significant risks are identified before they result in major inspection, product, supply, or compliance events. Audit, inspection, commitment, supplier, quality, and external regulatory intelligence are integrated into a common enterprise risk view. Audit scope and priorities respond dynamically to predictive signals, inspection outcomes, supplier performance, and external regulatory trends. Audit intelligence strengthens RRIR inspection readiness and response strategy. ILM receives timely audit information to support inspection scoring, lessons learned, and commitment oversight. Recurring findings decrease, systemic issues are identified earlier, and corrective actions are sustainable. Auditor technical capability improves against defined competency standards. AI-enabled tools improve risk detection and audit effectiveness while maintaining human accountability and audit independence. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications Basic Qualifications: Doctorate degree and 5 years of biologics manufacturing and