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

** 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…