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IT Quality - AI Specialist

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Amgen

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Location:
India , Hyderabad

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Category:
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Contract Type:
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Salary:

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Job Description:

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).

Job Responsibility:

  • 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

Requirements:

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

Additional Information:

Job Posted:
April 22, 2026

Work Type:
On-site work
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