Amgen
IT Quality - AI Specialist
Job Description
**Position Summary / Purpose**
This role is accountable for the end-to-end global process that ensures AI-enabled systems used in GxP contexts are validated/qualified and maintained in a state of control throughout their lifecycle, consistent with the company’s Quality Management System (QMS) expectations for global process ownership and controlled document architecture.
This role is validation/qualification-specific and operates in partnership with the existing global Business Process Owner (BPO) for Responsible Use of AI for GxP, who owns overarching responsible-use governance and user controls (e.g., human-in-the-loop expectations and usage constraints) and good understanding on the Global AI Regulatory requirements (EU Act, FDA).
**Scope**
Applies to AI systems, models, and tools (standalone or embedded) used to generate information or data supporting GxP-regulated activities, including the validation pathway that incorporates AI trustworthiness/...
This role is accountable for the end-to-end global process that ensures AI-enabled systems used in GxP contexts are validated/qualified and maintained in a state of control throughout their lifecycle, consistent with the company’s Quality Management System (QMS) expectations for global process ownership and controlled document architecture.
This role is validation/qualification-specific and operates in partnership with the existing global Business Process Owner (BPO) for Responsible Use of AI for GxP, who owns overarching responsible-use governance and user controls (e.g., human-in-the-loop expectations and usage constraints) and good understanding on the Global AI Regulatory requirements (EU Act, FDA).
**Scope**
Applies to AI systems, models, and tools (standalone or embedded) used to generate information or data supporting GxP-regulated activities, including the validation pathway that incorporates AI trustworthiness/...