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

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.

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