Major Accountabilities

Enterprise CSV & Digital Quality Leadership

Define and execute the enterprise-wide CSV & Digital Quality strategy.
Establish and maintain a long-term roadmap for digital quality capabilities and compliance frameworks.
Provide enterprise-level oversight of GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies.
Act as the senior Quality advisor for digital transformation initiatives and emerging technologies.
Represent Digital Quality during regulatory inspections, audits and governance boards.

Enterprise Governance & Compliance

Establish and maintain governance frameworks for computerized systems, AI solutions, cloud platforms, automation technologies and digital products.
Ensure compliance with global GxP requirements, Annex 11, 21 CFR Part 11, Data Integrity principles, GAMP5, CSA and applicable AI regulations.
Define and drive risk-based validation and assurance approaches across the enterprise.
Ensure inspection readiness and regulatory compliance throughout the digital solution lifecycle.





End-to-End Digital Quality Oversight

Maintain an enterprise-wide view of digital quality processes, systems, data flows and interfaces across functions.
Ensure end-to-end oversight and alignment from business requirements, design and implementation through operation, monitoring and continuous improvement.
Drive harmonization, simplification and standardization of digital quality processes globally.
Identify opportunities to leverage digitalization, automation and AI to improve compliance, efficiency and business outcomes.

AI, Data & Automation Governance

Establish and maintain governance for AI, Generative AI, advanced analytics and intelligent automation solutions.
Ensure appropriate qualification, validation, monitoring and lifecycle management of GxP-relevant AI solutions.
Define controls for explainability, traceability, risk management and regulatory compliance.
Provide quality oversight for

📌 Head GQS CSV (India)
🏢 Sandoz India
📍 India