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

Amgen

. Serve as the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $198,331 - $268,330 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP/GDP compliance, audit strategy, and risk management within the pharmaceutical or biotechnology sectors. Proven ability to lead multidisciplinary teams, develop predictive compliance capabilities, and provide actionable insights on compliance risks.

Highest-signal resume keywords

GMP/GDP ComplianceGlobal Audit LeadershipRisk ManagementAI-Enabled Compliance ToolsPharmaceutical Quality Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biologics ManufacturingRegulatory ComplianceAudit PlanningData StrategyPredictive ModelingQuality System EvaluationCAPA AssessmentSupplier Quality ManagementInspection ReadinessCompliance Analytics

Soft Skills

LeadershipInfluencingCross-Functional CollaborationDecision-MakingTeam Development

Tools & Technologies

AI ToolsCompliance Intelligence ToolsData Analytics PlatformsDashboard Development

Industry Keywords

PharmaceuticalBiotechnologyQuality AssuranceRegulatory AffairsGlobal Health Authority Standards

About the role

Key responsibilities & impact

Serve as the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability
Establish strategic direction, operating model, technical standards, and multiyear roadmap
Lead the global risk-based GMP/GDP audit strategy and master audit schedule
Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure
Evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities
Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multisite evaluation, or executive escalation
Build the predictive compliance intelligence capability, including 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 an enterprise risk view
Develop predictive models, dashboards, early-warning indicators, and risk scenarios
Identify systemic risks and recurring failure mechanisms
Lead auditor technical capability strategy, competency requirements, qualification standards, continuing education, and subject-matter expertise access
Oversee AI-enabled audit and compliance intelligence tools while maintaining human judgment, Quality accountability, audit independence, and objective evidence
Advise the enterprise AI governance organization on GMP/GDP matters
Provide senior leadership with actionable insight on emerging compliance risks and recommended interventions
Lead and develop a multidisciplinary global audit and compliance intelligence organization
Own the audit continuous-improvement roadmap and measures of audit effectiveness
Partner with RRIR, ILM, and External Affairs on inspection readiness, inspection outcomes, regulatory trends, and compliance priorities

Requirements

What you’ll need

Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience OR master’s degree and 9 years of experience OR bachelor’s degree and 11 years of experience
At least 5 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources
Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related disciplines
Depth in Operations GMP/GDP compliance
Ability to independently evaluate complex manufacturing, laboratory, quality-system, supplier, and distribution risks
Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization
Experience building or substantially transforming an enterprise capability, program, or operating model
Experience applying analytics, AI, or digital tools to compliance and risk management
Strong knowledge of global health-authority inspection expectations and enforcement trends
Ability to identify emerging risk, make difficult compliance judgments, and influence enterprise decisions
Ability to lead multidisciplinary teams and senior cross-functional stakeholders

Benefits

Comp & perks

Retirement and Savings Plan with generous company contributions
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 possible
Career development opportunities
Work/life balance support