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 recent 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

📌 IT Validation (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru