Summary

About the role:

The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures.

eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects.

About The Role

Key Requirements:

• Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)
• Drive the design, deployment and continuous improvement of automation and AI-enabled solutions within assigned processes.




• Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
• Supports the development of future-focused strategy in AI and emerging technologies readiness, evaluating regulatory requirements and developments to ensure Novartis QMS is fit for purpose in the eCompliance setting.
• Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
• Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
• Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
• Review and approve the GxP Changes and the associated deliverables. Review and approve the GxP impacted deviations,

📌 eCompliance Manager (India)
🏢 Novartis India
📍 India