IT Validation & Compliance Analyst II

IT Validation & Compliance Analyst II

Department - ClinOps and Regulatory GBS

Organization – Novo Nordisk Global Business Services (GBS) India

Ensure the systems behind life-changing therapies meet the highest standards of quality and compliance – from release to retirement.

Your new role

As an IT Validation & Compliance Analyst II in Clinical Data Solutions GBS, you will be responsible for end-to-end validation of GxP-critical systems, ensuring sustained compliance with regulatory and company requirements throughout their lifecycle. You will play a central role in driving release activities, coordinating validation efforts, and strengthening the team's quality culture.

Your key responsibilities will include:

• Preparing and owning the release plan for system releases, developing implementation plans, and driving all release-related activities end-to-end
• Collaborating with the Line of Business, vendors, and other relevant stakeholders to ensure successful delivery of projects and compliant execution of validation activities
• Updating and reviewing impacted documentation – including URS, CS, FS, DS, and other controlled documents – in line with the approved change/release scope
• Leading and coordinating validation activities required to support each release, ensuring appropriate documentation, traceability, and quality oversight
• Drafting, executing, reviewing, and approving test cases (manual and/or automated using tools such as Leapwork, TOSCA), ensuring results meet defined acceptance criteria and compliance requirements
• Managing incidents and deviations using platforms such as ServiceNow and Vault Quality, ensuring timely investigation support and appropriate follow-up actions
• Maintaining IT risk assessment documentation, O&M SOPs, and compliance documents to support ongoing audit and inspection readiness
• Mentoring and coaching colleagues in the validation specialty area, sharing quality-related knowledge and best practices to build capability and consistent execution standards
• Continuously improving and streamlining processes within your area of responsibility by identifying opportunities and sustaining better ways of working

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

Within Research & Development, Clinical Data Solutions GBS plays a critical role in ensuring the systems that support clinical data remain validated, compliant, and fit for purpose. You will join a team that values precision, collaboration, and continuous improvement – working closely with cross-functional partners to uphold the quality standards that ultimately protect patients and enable innovation.

Your skills & qualifications

We are looking for a detail-oriented professional who thrives in a regulated environment and takes ownership of quality outcomes. You'll bring with you:

• Total 6 years of industry experience, of which at least 4 years must be in software testing and at least 5 years must be hands-on experience working with pharmaceutical/GxP requirements for regulated systems and applications
• Strong knowledge of GxP validation principles, regulatory requirements, and lifecycle management of computerised systems
• Experience with test automation tools (e.g., Leapwork, TOSCA) and incident/deviation management platforms (e.g., ServiceNow, Vault Quality)
• Ability to work independently, proactively manage assigned tasks, and communicate effectively with diverse stakeholders Strong mentoring and collaboration skills, with the ability to coach others and drive consistent execution standards across teams
• A relevant degree in IT, Life Sciences, Engineering, or a related discipline

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.

Contact

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

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

11th August 2026. Applications are reviewed on an ongoing basis.

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.