Global GMP/GDP Audit & Predictive Compliance Leader

Amgen Inc. (IR)

Thousand Oaks (CA)

Hybrid

USD 198,000 - 268,000

Full time

5 days ago

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Job summary

Amgen Inc. is seeking a Senior Director in Thousand Oaks, CA to lead global GMP/GDP audits and predictive compliance intelligence. You will unite audit assurance, regulatory compliance, analytics, and AI tools to drive early risk detection and proactive interventions.

The role requires advanced degrees with extensive biologics compliance leadership experience, and a proven ability to manage a global, multidisciplinary audit team. This position offers a high-impact career path.

Qualifications

Doctorate or Master’s with required years of experience in biologics manufacturing and regulatory compliance.
Experience managing people and leading teams, projects, or programs.
Strong knowledge of GMP/GDP quality systems and inspections.

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.
Build the predictive compliance intelligence capability, including its data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures.