About

Raj Nandhan R M is a highly experienced Quality Assurance specialist with over 18 years of experience in the software, manufacturing (Medical Devices), and Life Sciences (Pharmaceutical) industries. He has held both technical and management roles, and his expertise lies in Quality Management, GxP, Regulatory Compliance, and AI/ML Validation. Currently, Raj is working as an Assistant Vice President - QA / Compliance Quality Lead at Genpact. In this role, he ensures Computer System Validation (CSV) in GxP/regulatory space, defines, implements, and maintains processes, and ensures compliance against defined QMS processes. He is part of a team developing a product to disrupt the PharmacoVigilance processes using Artificial Intelligence (AI) & Machine Learning (ML) and is directly involved in defining, managing, and validating AI/ML based software in GxP/regulatory space. He is also accountable for defining, implementing, and maintaining Genpact PVAI Quality Management System in line with GAMP 5, ISO 9001, ISO 27001 & 21 CFR Part 11. Raj leads a global team that provides cross-functional QA expertise and serves as the primary global QA resource supporting all areas of technology/SDLC, Infrastructure, testing, and compliance throughout the organization. He is accountable for validating the cloud infrastructure and Computer Systems managed (provided as Software as Service) by Genpact PVAI are fit for intended use and compliant with applicable regulations (e.g. 21 CFR Part 11). He also conducts quality and compliance assessments and represents Genpact in external/supplier audits. Prior to his current role, Raj worked as a Senior Quality Assurance Manager at Genpact and as a Quality Manager at Genisys Group. At Genisys Group, he established, organized, and promoted organization-wide quality policies and procedures and owned the complete responsibility of all Quality functions at an enterprise level. Raj holds a Master's degree in Information Technology from Punjabi University and a Master's degree in Computer Science from Bharathidasan University. He is proficient in QA, AI, ML, infra, and test and has 18.53 years of relevant experience.