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Tier-1 pharma brand and metro location increase competition, though senior GxP/AI specialization narrows candidate pool.
Highly specific GxP, CSV, and AI validation requirements limit transferability across industries.
Explicit 12/14 years requirement plus mandatory GxP CSV and AI validation expertise.
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Provide strategic leadership and quality oversight for GxP computerized systems validation, Computer Software Assurance (CSA), and AI validation frameworks across the enterprise.
Lead programs ensuring computerized systems and AI-enabled solutions remain compliant, validated, and maintained in a state of control throughout their lifecycle.
Drive continuous improvement, risk-based validation practices, inspection readiness, and governance for emerging digital technologies including AI.
Master’s degree with minimum 12 years or Bachelor’s degree with minimum 14 years in Quality Assurance, Computerized Systems Validation, IT Quality, or related regulated environments.
Experience leading global programs and cross-functional teams within GxP-regulated environments with computerized systems like SAP/S4 HANA, LIMS, ELN, MES, Veeva Vault, TrackWise, or cloud platforms.
Demonstrated expertise in AI validation, qualification, lifecycle management, and governance within GxP contexts.
Must work onsite at Amgen Hyderabad office as per site policy.
Experienced in managing strategic, cross-functional initiatives to implement risk-based validation and Computer Software Assurance methodologies within a regulated biopharma IT environment.
Strong capability to lead AI validation programs aligned with global regulatory requirements, collaborating with AI SMEs, Data Scientists, and quality stakeholders.
Proven ability to influence senior leadership and drive enterprise-wide quality, compliance, and digital transformation initiatives with data-driven decision making.