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 current 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 an

📌 IT Validation (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru