Job Description Summary
LI-Hybrid

Location: Hyderabad, India

As a Senior eCompliance Manager you ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure. Provide oversight and guidance in the development and implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within IT systems landscape. Closely cooperate with functional IT staff in the compliant development and delivery of computerized systems to meet GxP requirements. Review and approve CSV deliverables for all Global GxP relevant systems including determination of GxP applicability.

Job Description
Key Responsibilities:

• Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP and AI regulated computerized systems and associated infrastructure.
• Contribute to developing a future-focused strategy for AI and emerging technology readiness,



evaluating regulatory requirements and developments to ensure the Novartis QMS remains fit for purpose in the eCompliance setting.
• Lead the implementation, scaling and adoption of approved automation and AI capabilities within assigned eCompliance domains.​
• Provide oversight, and guidance in the development and implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within IT systems landscape.
• Single Point of Contact for all CSV related matters for GxP Global 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.
• Establish trusted partnership with assigned IT Function with understanding of business drivers, strategic roadmap and its impact on the eCompliance team.
• Review and approve project related doc

📌 Senior Ecompliance Manager Hyderabad
🏢 Novartis
📍 Hyderabad