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

Career Category

Quality

Job Description

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, governed, and maintained in accordance with Amgen’s Quality Management System (QMS), global regulatory requirements, and industry best practices.

The individual will be required to work from our office located in Hyderabad, India (Amgen India-AIN). The candidate will be required to work from the office as dictated by site policy.

As a Senior Manager within the IT Quality organization, you will provide leadership, strategic direction, and quality oversight for teams supporting various phases of the Information Systems Lifecycle within a GxP-regulated environment.

Leadership Responsibilities

• Responsible for managing and developing a high-performing team, providing leadership and guidance on Quality, Computerized Systems Validation, CSA, AI Validation, and GxP compliance activities.

• Provide strategic leadership and quality oversight for computerized systems validation, AI validation, and digital quality initiatives.

• Drive organizational adoption of risk-based validation and Computer Software Assurance (CSA) methodologies.