Bikash Sarkar

Driving Enterprise QMS Transformation, Regulatory Compliance, GxP Governance and Audit Readiness across global pharma and medical device ecosystems.

· Enabling Risk-Based Quality, CAPA Optimization, CSV & Data Integrity, Digital Quality Transformation and Compliance Analytics for scalable, inspection-ready organizations.

Where Can I Add Value

· Build and scale enterprise QMS frameworks aligned with FDA, EMA, ICH and ISO 13485.

· Strengthen audit readiness through risk-driven audit strategy and inspection preparedness programs.

· Transform CAPA, deviation and change control systems to improve lifecycle efficiency and compliance outcomes.

· Lead digital quality initiatives using compliance analytics, dashboards and KPI-driven governance.

· Establish robust supplier quality and third-party risk management frameworks across global supply chains

Key Achievements.

· Delivered consistent zero critical observations across global regulatory inspections including FDA and ISO audits.

· Reduced major audit findings by 40% through systemic CAPA and quality event transformation.

· Accelerated enterprise-wide digital QMS adoption enabling real-time compliance visibility and decision-making.

· Enhanced audit lifecycle efficiency with risk-based planning and improved coverage across high-risk domains.

· Strengthened global compliance posture across multi-country operations through harmonized quality systems.

About Me: A strategic and detail-oriented professional known for leadership, analytical thinking, cross-functional collaboration and clear communication, with a strong ability to align quality with business priorities.

 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