Department: Validation COE

Location: Novo Nordisk Global Business Services (GBS)

Are you passionate about ensuring compliance and validation in IT systems? Do you have the expertise to Lead validation strategies that safeguard patient safety and ensure every system meets the highest regulatory standards.? Are you passionate about integrating AI with Process excellence? If you are ready to take on a challenging and rewarding role, we invite you to join Novo Nordisk as our recent Senior Validation & Compliance Specialist. Read on and apply today

The position

As a Senior Validation & Compliance Specialist, you will:
- Defining and executing risk-based validation strategies aligned with Novo Nordisk's Quality Management System, acting as a subject matter expert across both Agile and V Model methodologies
- Performing comprehensive assessments including IT Risk Assessments (ITRA), IT Requirements Risk Assessments (ITRRA), and quality, functional, data integrity and supplier assessments
- Authoring, reviewing and executing end-to-end validation deliverables,



managing test strategies and reporting in line with Software Testing Life Cycle (STLC)
- Leading end-to-end change management, performing root cause analysis using 5 x Why methodology, and managing CAPA processes during both project and operation phases
- Serving as Service Manager for multiple concurrent projects, managing service delivery, stakeholder relationships, and resource allocation across diverse international teams
- Participating in audits and inspections, identifying compliance gaps and proposing solutions to maintain regulatory standards
- Mentoring junior colleagues and driving process enhancements through automation strategies that optimise workflows and improve operational efficiency.
- Take initiative to recognize, develop, and execute process enhancements and automation strategies (could be AI) that optimise workflows, reduce manual intervention, and drive operational efficiency.
- Experience in de

📌 Sr IT Validation (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru