IT Quality -Senior Manager – Computerized Systems Validation /Assurance & AI

Position Summary

Join Amgen’s mission of serving patients by providing strategic leadership, quality oversight, and global process stewardship for GxP computerized systems, AI-enabled technologies, and emerging digital solutions.

The Senior Manager, Global IT Quality, Computerized Systems Validation & AI Assurance is responsible for advancing risk-based validation practices, Computer Software Assurance (CSA), AI validation and qualification frameworks, inspection readiness, and continuous improvement initiatives across the enterprise. This role ensures computerized systems and AI-enabled solutions remain compliant, validated, and maintained in a state of control throughout their lifecycle.

The position partners closely with Business Owners, System SMEs, IT Application Owners, AI Model SMEs, Digital Technology & Innovation teams, and the Global Business Process Owner (BPO) for Responsible Use of AI in GxP to ensure AI-enabled systems are validated, qualified, ...

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