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

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary accountable leader for Amgen’s global GMP/GDP audit organization along with the predictive compliance intelligence capability.

• Define the strategic direction, operational model, technical standards, and multi-year roadmap.

• Direct the global risk-based GMP/GDP audit strategy and master audit schedule.

• Manage the audit planning, scope, execution, findings classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure processes.

• Assess manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities.

• Identify situations when emerging risks necessitate an expanded audit scope, targeted assessments, for-cause audits, multisite evaluations, or executive escalations.

• Develop the predictive compliance intelligence capability, which includes data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance metrics.

• Consolidate audit data, inspection results, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into a comprehensive enterprise risk perspective.

• Create predictive models, dashboards, early-warning indicators, and risk scenarios.

• Recognize systemic risks and recurring failure mechanisms.

• Direct the auditor technical capability strategy, competency requirements, qualification standards, ongoing education, and access to subject-matter expertise.

• Supervise AI-enabled audit and compliance intelligence tools while ensuring human judgment, quality accountability, audit independence, and objective evidence are maintained.

• Counsel the enterprise AI governance organization on GMP/GDP issues.

• Provide senior leadership with actionable insights regarding emerging compliance risks and suggested interventions.

• Lead and nurture a multidisciplinary global audit and compliance intelligence organization.

• Own the continuous-improvement roadmap for audits and metrics of audit effectiveness.

• Collaborate with RRIR, ILM, and External Affairs on inspection readiness, inspection outcomes, regulatory trends, and compliance priorities.

⛳️ Requirements

• Doctorate degree with 5 years of experience in biologics manufacturing and regulatory compliance OR master’s degree with 9 years of experience OR bachelor’s degree with 11 years of experience.

• Minimum of 5 years’ experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• Extensive leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related fields.

• In-depth knowledge of Operations GMP/GDP compliance.

• Capability to independently assess complex risks in manufacturing, laboratory, quality systems, suppliers, and distribution.

• Experience in leading a global audit, supplier quality, inspection readiness, quality system, or compliance intelligence organization.

• Proven experience in building or significantly transforming an enterprise capability, program, or operating model.

• Familiarity with applying analytics, AI, or digital tools to compliance and risk management.

• Strong understanding of global health authority inspection expectations and enforcement trends.

• Ability to detect emerging risks, make challenging compliance decisions, and influence enterprise-level decisions.

• Proficient in leading multidisciplinary teams and engaging senior cross-functional stakeholders.

🏝️ Benefits

• Retirement and Savings Plan with generous company contributions.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.