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

Amgen · Remote +1 more

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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Date posted1 day ago

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