Company: Novo Nordisk Global Business Services (GBS)
Shape how Novo Nordisk validates the IT systems that power our development, manufacturing and commercial operations – and help us redefine what valuable looks like in IT Quality and Compliance. If you are energised by complex regulatory landscapes, AI-enabled validation and the chance to influence how an entire enterprise approaches CSV and CSA, read on.
Your new role
As a Senior IT Validation & Compliance Specialist in our Compliance & Reporting Services (CRS) team, you will act as a senior Validation Subject Matter Expert (SME) and trusted advisor for high-impact GxP IT systems, computerised equipment and supporting infrastructure. You will combine deep technical expertise with risk-based thinking to drive lean, audit-ready validation across the full system lifecycle, while championing the integration of AI and automation into our validation practices.
Your day-to-day responsibilities will include:
- Defining and driving validation strategies,
standards and approaches for complex GxP IT systems, ensuring alignment with the Novo Nordisk Quality Management System (NN QMS) and global stakeholder expectations
- Authoring and reviewing critical validation deliverables – including Implementation Plans, Implementation Reports, IT Risk Assessments, O&M; SOPs and Periodic Compliance Reports – and governing those authored by external partners
- Applying AI/ML concepts within GxP validation – from defining risk-based strategies for adaptive models and decision logic to leveraging AI tools for test generation, anomaly detection and compliance monitoring
- Creating and/or utilizing AI agents to cut down the validation cycle lead time and bring in efficiencies
- Be part of the process office and actively drive process simplication initiatives
- Supporting audits and inspections, performing Root Cause Analysis (5-why or similar) and driving Corrective and Preventive Actions (CAPA) to
📌 Sr. IT Val. (Bengaluru)
🏢 novonord
📍 Bengaluru
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