IT Quality- QA AI Specialist

• Maintain a compliant global quality process for AI validation/qualification and ensure alignment with QMS architecture and global documentation expectations.
• Define and maintain the global procedural framework for validating AI-enabled GxP systems, including integration points with system validation/SDLC expectations and responsible-use controls.
• Ensure the process is risk-based and scaled to AI context of use and impact, with clear decision gates and required evidence expectations.
• Robust understanding on the LLM and Machine development life cycle approaches.
• Able to support in shifts based on the project needs in EST, PST Timezone.

• Own/maintain the core global procedures and templates supporting AI validation/qualification, including credibility/trustworthiness assessment documentation and controlled report formats.
• Ensure documents are periodically reviewed and revised consistent with QMS role expectations for global process ownership.

• Partner with the Responsible Use BPO and governance stakeholders to ensure validation/qualification requirements align with responsible-use constraints (e.g., independent human verification and traceability expectations).
• Coordinate with QA, Business Owners, System SMEs/IT Application Owners, and AI Model SMEs to ensure validation deliverables reflect business, compliance, and IS requirements and are stored in appropriate controlled repositories.

• Provide execution guidance, coaching, and job aids to sites/functions on implementing the global AI validation/qualification process locally while maintaining global consistency.
• Contribute to training curricula and support communities of practice to build consistent capability across the network.

• Define and communicate process performance metrics and drive continuous improvement opportunities.
• Support inspection readiness by ensuring validation evidence expectations are clear, auditable, and consistently applied.

• Process authority for the global AI validation/qualification procedure, templates, and required records.
• Authority to set minimum global validation expectations and recommend/drive harmonization decisions through established governance.

• Global BPO – Responsible Use of AI in GxP
• Quality Assurance (GxP computerized systems validation)
• Business Owners, System SMEs / IT Application Owners
• AI Model SMEs (data science/statistical credibility)
• Cross-functional governance stakeholders (e.g., privacy, cybersecurity, sourcing, architecture) as applicable

• Master’s degree with a minimum of 10 years experience in Software and Systems Quality assurance OR
• Bachelor’s degree with a minimum of 12 years of Software and Systems Quality assurance experience

• Demonstrated experience in GxP computerized systems validation/qualification and lifecycle management.
• Experience developing, maintaining, and deploying controlled documents and templates within a regulated QMS environment.
• Familiarity with AI governance expectations in GxP contexts, including responsible-use constraints such as human oversight and independent verification.
• Working knowledge of AI trustworthiness/credibility assessment concepts and documentation practices used to support validation decisions.

• Strong process orientation and document quality discipline (controlled documentation, traceability, clarity).
• Ability to influence without authority across global, cross-functional stakeholders.
• Risk-based thinking and ability to translate policy/standards into practical, scalable validation deliverables.
• Clear written and verbal communication; training and coaching capability.

Amgen