The Software Validation Manager is responsible for leading and continuously evolving the Computer Software Validation (CSV) and Computer Software Assurance (CSA) program supporting GxP computerized systems across global business functions. This role provides strategic leadership, governance, and oversight for validation activities throughout the computerized system lifecycle while ensuring compliance with global regulatory requirements, industry standards, and company quality standards.
The Software Validation Manager leads and develops the validation team while partnering with Business, Information Technology, Quality, Regulatory Affairs, Engineering, Cybersecurity, and external vendors to establish validation strategies, oversee execution of validation programs and projects, implement risk-based Computer Software Validation/ Assurance practices, and drive continuous improvement and operational excellence across the validation organization.
This e role supports regulatory inspections and audits and provides oversight of supplier validation resources and deliverables throughout project executions. It also supports the adoption of modern technologies including Cloud, SaaS, AI-enabled applications, enterprise system integrations, and data migration/transformation initiatives while maintaining inspection readiness and ensuring patient safety, product quality, and data integrity.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
Shift Timing - 8:00 AM - 5:00 PM
