eCompliance Manager – Computerized Systems Validation (CSV)
Job ID: REQ-10065599
Location: Hyderabad, India
Posted on: November 03, 2025
Job Type: Full Time | Regular
Functional Area: Quality
Position Summary
The eCompliance Manager plays a critical role in ensuring Quality Assurance oversight for GxP-regulated computerized systems. This position is responsible for delivering expert guidance on Computerized Systems Validation (CSV) in alignment with global regulatory expectations such as GxP, 21 CFR Part 11, the Novartis Quality Manual and global quality procedures.
You will oversee validation deliverables, support day-to-day compliance operations, review and approve GxP-related documentation, and act as a key interface between IT, Business, and Quality functions to maintain a strong compliance culture across all system-related activities.
Key Responsibilities
Quality Compliance Oversight
Ensure robust quality oversight of all operational activities related to GxP systems, including change controls, deviations, and periodic reviews.
Ensure compliance with Novartis standards and applicable regulatory requirements for GxP computerized system projects.
Serve as the primary CSV point of contact for all GxP-relevant systems and interface between IT and Business units to support eCompliance topics.
Documentation & Validation Governance
Review and approve project documentation, including GxP applicability assessments for both GxP and non-GxP systems.
Review and approve GxP changes, validation deliverables and associated documentation.
Ensure deviations are managed appropriately with effective CAPA actions and quality-driven resolutions.
Support preparation and execution of Validation Master Plans (VMP) across assigned systems.
Operational & Process Support
Review and approve Periodic Review Reports for GxP computerized systems and ensure identified gaps are managed through the CAPA Management System.
Conduct supplier qualification and evaluation activities for computerized systems and services.
Provide support during audits and ensure CSV documentation is readily available and inspection-ready.
Stakeholder Engagement
Establish strong partnerships with IT and Business teams by understanding system requirements and providing operational compliance guidance.
Promote a culture of continuous improvement, transparency, and proactive quality engagement.
Essential Requirements
Strong ability to ensure GxP computerized systems are implemented and maintained according to Novartis and regulatory guidelines.
Proven experience in timely review and approval of changes, deviations, and system periodic reviews.
Ability to maintain accurate, up-to-date documentation for audits and regulatory inspections.
Strong skills in identifying compliance gaps, escalating issues, and supporting mitigation plans.
Ability to manage stakeholder expectations and deliver high-quality feedback.
Experience Requirements
Demonstrated experience in CSV, eCompliance or Quality Assurance within a GxP-regulated environment.
Experience supporting cross-functional teams and working across IT and Business boundaries.
Background in project management and quality oversight preferred.
Experience in people leadership or influencing roles is an added advantage.
Desirable Skills
Functional breadth across IT, Quality and Compliance domains.
Ability to collaborate across global boundaries and diverse teams.
Strong analytical, documentation and problem-solving skills.
Knowledge of CAPA processes, risk management and supplier qualification.
Why Join Novartis
Novartis aims to reimagine medicine and deliver innovative, trusted solutions that improve and extend patients’ lives globally. Every associate contributes to this mission through collaboration, innovation and dedication. Learn more about our people-centric culture via the Novartis strategy and culture resources.
Benefits & Rewards
A comprehensive set of benefits and career development opportunities is available through the Novartis Life Handbook. Candidates can explore professional growth, learning and performance-based rewards across the organization.
Diversity & Inclusion Commitment
Novartis is dedicated to creating a diverse, inclusive, and equitable workplace that reflects the communities and patients it serves. Individuals with disabilities in need of reasonable accommodation during the recruitment process may contact:
Email: diversityandincl.india@novartis.com
Please include the job requisition number with your inquiry.
Company & Location Details
Division: Operations
Business Unit: Quality
Site: Hyderabad (Office), India
Company: Novartis Healthcare Private Limited
Shift Work: No
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