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

🕒 Setembro 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $198.330 - $268.329 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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