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

Senior Director leads Amgen's global GMP/GDP audit organization and predictive compliance intelligence function. The role establishes strategic direction, oversees audit operations across manufacturing and supplier networks, and builds advanced analytics capabilities to identify emerging compliance risks and enable proactive enterprise intervention.

Responsibilities

• Establish strategic direction, operating model, and multiyear roadmap for global audit and predictive intelligence capabilities
• Lead global risk-based GMP/GDP audit strategy and master audit schedule across internal sites, suppliers, and contract manufacturers
• Build and oversee predictive compliance intelligence capability including data strategy, analytical methods, and AI-enabled tools
• Integrate audit data, inspection outcomes, regulatory trends, and quality signals into consolidated enterprise risk view with early-warning indicators
• Lead multidisciplinary global audit organization; set competency standards, qualification requirements, and continuing education programs

Requirements

• Extensive GMP/GDP audit experience and deep manufacturing operations compliance expertise
• Proven leadership of large, geographically distributed quality or audit organizations
• Advanced analytics, AI/machine learning, and predictive modeling knowledge
• Strong regulatory intelligence and inspection readiness experience
• Strategic capability-building and organizational development experience
• Technical depth in quality systems, data integrity, and manufacturing processes