[Hiring] Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. The Senior Director is the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability.

• 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.
• Accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program.
• Builds a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention.
• Leads two fully integrated capabilities:
  • Global GMP/GDP Audit
  • Predictive Compliance Intelligence

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.
• 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.
• Oversee AI-enabled audit and compliance intelligence tools.
• 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.

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.
• Significant risks are identified before they result in major inspection, product, supply, or compliance events.
• Audit scope and priorities respond dynamically to predictive signals, inspection outcomes, supplier performance, and external regulatory trends.
• Recurring findings decrease, systemic issues are identified earlier, and corrective actions are sustainable.
• AI-enabled tools improve risk detection and audit effectiveness while maintaining human accountability and audit independence.

Qualifications

• Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience OR
• Master’s degree and 9 years of biologics manufacturing and regulatory compliance experience OR
• Bachelor’s degree and 11 years of biologics manufacturing and regulatory compliance experience
• At least 5 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

• Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related disciplines.
• Demonstrated depth in Operations GMP/GDP compliance.
• Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization.
• Experience applying analytics, AI, or digital tools to compliance and risk management.
• Strong knowledge of global health-authority inspection expectations and enforcement trends.
• Demonstrated ability to lead multidisciplinary teams and senior cross-functional stakeholders.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Salary Range

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is 198,330.50 USD - 268,329.50 USD.