Sr IT Validation & Compliance Specialist I

Department SI&C - Validation CoE
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 Nordisks 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 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:

• Bachelors 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 projects2 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

Enterprise IT in GBS works across Research & Early Development Manufacturing Commercial Operations and Information Security. Located at Novo Nordisks global headquarters the department enables all efforts towards bringing digital solutions to our patients across the globe. The atmosphere is dynamic and fast-paced fostering collaboration and innovation to drive impactful results. With a global reach the team ensures alignment and integration of cutting-edge technologies across Novo Nordisks network.

Validation CoE team of ServiceNow Integrations & Compliance unit is responsible for compliance management of systems at Novo Nordisk in areas like: IO EIT&Q FL&GS R&D NNI PO&C CMC&PS etc. The systems are used on a local regional and global scale by many areas of the business including Sales and Marketing Production sites etc. and are critical to the execution of key business process such as development manufacturing sales finance etc. This team is responsible for validation of these systems/ Qualification of underlying infrastructure and maintaining the systems in the validated state throughout in its operation.

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.

Contact

To submit your application please upload your CV online (click on Apply and follow the instructions).

Apply Now!

Deadline

11-Mar-2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve 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 whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were 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.