CSV IT - AGM

Role purpose: Lead risk-based validation and lifecycle compliance for GxP computerized systems globally, while strengthening Amneals IT CSV/SDLC Center of Excellence and enabling secure, scalable digitization across Manufacturing, Quality and Laboratory operations.

Key Responsibilities

• Own the end-to-end CSV lifecycle for new implementations, upgrades, integrations, migrations and decommissioning of GxP systems, using a risk-based and Computer Software Assurance (CSA) approach.
• Author, review and approve validation plans, URS, functional/configuration specifications, risk assessments, test protocols, traceability matrices, deviations, change controls and validation summary reports.
• Establish and continuously improve global CSV/SDLC policies, procedures, templates, controls and metrics; drive consistent adoption across U.S., India and other operating locations.
• Partner with IT, Quality, Manufacturing, Engineering, Laboratory, Security, Data and business teams to embed compliance, data integrity and security requirements throughout the system lifecycle.
• Provide validation leadership for enterprise and GxP platforms, including SAP/ERP, MES/eBR, LIMS, QMS, EDMS/LMS, laboratory instruments, PLC/SCADA and other manufacturing control systems.
• Assess cloud/SaaS, data, analytics and AI-enabled solutions for intended use, supplier controls, electronic records/signatures, model and data risks, auditability and ongoing validated-state requirements.
• Lead supplier assessments and validation deliverables; ensure vendor documentation is fit for purpose and effectively leveraged without transferring accountability from Amneal.
• Support regulatory inspections and internal/customer audits, respond to observations, and lead remediation through deviations, CAPA and change-management processes.
• Build and mentor a high-performing CSV team, manage priorities and resource capacity, and serve as the senior escalation point for complex validation and compliance decisions.

Required Qualifications

• Bachelors degree in Computer Science, Engineering, Life Sciences or a related discipline; advanced degree or relevant certification is preferred.
• 10+ years of experience in IT/Computer System Validation within pharmaceutical, biotechnology or another regulated life-sciences environment, including 3+ years leading people or major programs.
• Strong working knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, data integrity/ALCOA+ principles, SDLC, risk management, change control, deviation and CAPA.
• Demonstrated experience validating enterprise applications, laboratory systems and manufacturing/OT systems; strong written communication, stakeholder leadership and audit-facing skills.

Preferred Experience

Global/multi-site CSV governance; SAP S/4HANA; cloud and SaaS validation; automated testing or validation lifecycle tools; AI/ML governance; and experience establishing or scaling a CSV Center of Excellence.

Success Measures

Inspection-ready documentation • Consistent global validation practices • Predictable delivery and cycle times • Sustained validated state • Effective risk reduction • Strong stakeholder and team capability.