Nithin Nanaiah
Lead Auditor (Gcp Pv) @Novo Nordisk
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WORK HISTORY
Lead Auditor (Gcp Pv) @Novo Nordisk
Bengaluru, IN
Conduct global audits across clinical trial sites, CROs, HQs, and vendors.Draft detailed audit reports and ensure timely CAPA closure.Perform clinical protocol risk assessments to drive audit strategy.Identify compliance gaps and enforce corrective actions.Manage stakeholder alignment across cross-functional teams.Support global inspection readiness (FDA, EMA, etc.).Champion digitalization in quality systems and processes.Lead internal GCP and PV compliance training initiatives.Monitor QMS data to support quality management reviews.Ensure global regulatory compliance with ICH-GCP, GVP.
EDUCATION
Sri Bhagawan Mahaveer Jain College
BSc
JIVAS
Advance Diploma in Genetic Engineering
Jain Institute of Vocational & Advanced Studies
Diploma
Bangalore University
MSc
Symbiosis Institute of Business Management
Post Graduate Diploma in Operations Management
ABOUT NITHIN NANAIAH
A pragmatic Quality leader who acts as an early‑warning system for PV/GCP risk—helping…
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