Senior IT Validation and Compliance Specialist

Sr IT Validation & Compliance Specialist I

   

 

Department – Validation CoE Infra and Platforms

Organization: Novo Nordisk GBS, Bangalore

 

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 new 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 optimize workflows, reduce manual intervention, and drive operational efficiency.
• Experience in developing Merger and Acquisition strategies for large pharma organizations.
• Define and execute a risk-based validation and AI assurance strategy aligned with Novo Nordisk QMS and AI governance frameworks.
• Serve as SME for validation activities for traditional GxP computerised systems and AI/ML-enabled solutions across the product lifecycle.
• Ensure the validated/compliant state is maintained throughout system and model lifecycle including development, deployment, monitoring, and retirement.

 

 

Qualifications

We are looking for an experienced validation specialist who thrives in complex, regulated environments and enjoys driving compliance excellence. You will bring with you:

• Bachelor’s degree in computer science, Life Sciences, IT Quality, or a relevant field; industry-recognised ITIL and ISO quality management certification preferred.
• 8+ years of experience working in pharmaceutical or service-based organisations, preferably in the IT quality domain.
• 5+ years of practical experience in GxP areas with strong exposure to regulatory requirements including GAMP 5, 21 CFR Part 11, and EU Annex 11
• 5+ years performing root cause analyses, CAPA and other IT quality assurance activities, with proven expertise in validation for complex projects,2+ years of service management experience, including stakeholder management and service delivery across multiple concurrent projects.
• Excellent coaching and mentoring capabilities, with the ability to guide junior colleagues and represent Novo Nordisk with users and external stakeholders.
• Proficiency in MS Office Suite and strong time management skills, combined with the flexibility to work under pressure and drive change processes.
• Fluency in English (written and oral) with excellent interpersonal, communication and presentation skills across diverse cultures

 

About the department

In Quality, IT and Environmental Affairs, 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 Quality, IT and Environmental Affairs sits the Validation CoE team for ServiceNow, Integrations & Compliance. Our unit is responsible for compliance management of systems across Novo Nordisk areas including International Operations, Enterprise IT & Quality, Finance, Legal & Global Solutions, Research & Development, and CMC & Product Supply. These systems operate on local, regional, and global scales, supporting critical business processes in sales, marketing, production, development, manufacturing, and finance. Your role will be essential in validating these systems and maintaining their validated state throughout their operational lifecycle.

 

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 one hundred 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 are not just starting a job – you are 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 gain experience and develop are all around us, while our benefits are designed with your career and life stage in mind.

 

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.

Experience Level

Senior Level