Bikash Sarkar

Introduction: Good morning, and thank you for the opportunity to introduce myself. I am a Quality & Regulatory professional with 18+ years of experience in Medical Devices, Pharmaceuticals, and GxP-Regulated Environments. My expertise includes Enterprise QMS, ISO 13485, Regulatory Compliance, Audit Readiness, CAPA, Risk Management, and Digital Quality Transformation.

 Led enterprise Quality Management Systems (QMS) governance, eQMS transformation, ISO 13485 alignment, quality systems harmonization, global SOP standardization and lifecycle quality management across medical device and pharmaceutical organizations.

 Directed global regulatory compliance strategy and inspection readiness programs across US FDA (21 CFR Part 820 & Part 11), CDSCO, ICH, ISO 13485 and GxP frameworks, achieving zero critical regulatory observations and sustained audit readiness.

 Architected risk-based quality management frameworks incorporating FMEA, ICH Q9, CAPA, deviation management, change control, root cause analysis and quality event governance, reducing major audit findings by 40% and strengthening enterprise compliance effectiveness.

 Established Computer System Validation (CSV), GAMP 5 lifecycle validation, ALCOA+ data integrity controls, digital QMS transformation, compliance analytics, KPI dashboards and quality intelligence platforms to enable data-driven governance and executive decision-making.

 Strengthened enterprise governance through supplier quality management, vendor qualification, third-party risk management, audit lifecycle management, inspection risk mitigation and executive advisory on regulatory strategy, quality transformation and compliance risk across global operations.

MBA (Finance) – IIeBM, Pune – 2006