Department: Compliance & Reporting Services 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 good 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: <ul> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">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</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">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</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">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</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Creating and/or utilizing AI agents to cut down the validation cycle lead time and bring in efficiencies </li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Be part of the process office and actively drive process simplication initiatives</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Supporting audits and inspections, performing Root Cause Analysis (5-why or similar) and driving Corrective and Preventive Actions (CAPA) to closure</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Mentoring peers, fostering a strong IT Quality and Compliance mindset, and driving continuous improvement initiatives across CRS and SI&C GBS</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Engaging senior stakeholders across diverse cultures and disciplines to align on validation scope, escalate effectively and deliver against agreed SLAs</li> </ul> Your new department In Enterprise IT & Quality, you will be part of a business area that drives impact across the full Novo Nordisk value chain. We strive to stay close to our stakeholders in the business to ensure we deliver on their needs, helping reach millions of people living with serious chronic diseases. Our focus is on being at the forefront within our three areas; ensuring the highest quality for patients, being a trusted tech leader and an environmentally responsible business. Within Enterprise IT & Quality sits Compliance & Reporting Services (CRS), part of ServiceNow Integrations and Compliance GBS (SI&C GBS). We are accountable for the validation of IT systems, computerised equipment and underlying infrastructure that support Enterprise IT, Global Manufacturing & Supply, R&D – ensuring these business-critical systems remain in a validated state, in alignment with NN QMS and global regulatory requirements. As a senior member of our team, you will help shape how we govern compliance, embed AI into validation, and raise the IT Quality bar across the organisation. Your skills & qualifications We are looking for an experienced validation professional who combines deep regulatory expertise with curiosity about how AI and automation can transform compliance. You will likely bring with you: <ul> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">A Master's or Bachelor's degree (MCA, M.Sc. or B.Sc.) in Computer Science, IT Quality or a related field; ITIL and ISO Quality Management certifications are an advantage</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">13+ years' experience in a pharmaceutical or service-based organisation, preferably in IT Quality, with at least 10+ years of practical GxP exposure performing RCAs, CAPAs and IT quality assurance activities</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Strong working knowledge of regulatory requirements such as GAMP, 21 CFR Part 11 and EU Annex 11, combined with hands-on experience in Computer System Validation (CSV) and Computer Software Assurance (CSA)</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Demonstrated experience applying AI/ML concepts within GxP validation – including risk-based strategies for AI-enabled systems, ensuring data integrity and explainability, and using AI/automation tools to optimise validation</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Strong understanding of pharma value chain, exposure to regulatory inspections from various Health Authorities. </li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Exposure to ITIL Service Management, HP ALM, ADO, Veeva Vault Document Management System, Service Now, test management tools, and strong Microsoft Office skills</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Familiarity and exposure to AI concepts, AI powered chatbots, AI LLM models, building AI agents to bring in efficiency, validating AI models.</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Excellent written and spoken English, strong critical and analytical thinking, attention to detail and the ability to influence senior stakeholders across cultures and disciplines</li> </ul> Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. Deadline- 23 June 2026 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Sr. IT Val. & Comp. Specialist I (Bangalore, Karnataka, IN) @ novonord

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