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

🔥 4 hours ago

🇺🇸 United States – Remote

💵 $198.3k - $268.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

• 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

• 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