Subhransu Das

About Subhransu Das

As a Quality Assurance Leader with 18+ years in pharmaceuticals and biologics, I specialize in building inspection-ready Quality Management Systems (QMS) that not only ensure compliance but also enable innovation. My expertise spans QMS design, SaaS platforms (Veeva, MasterControl, TrackWise), digital transformation, CSV, and global regulatory compliance.I thrive at the intersection of compliance and technology, helping organizations strengthen inspection readiness, accelerate approvals, and deliver life-changing therapies to patients faster.At BBL, I\'m accountable for Develop, Lead, Manage, Harmonize and timely Implement Quality System, align Quality system for both Drug and Devices with regulatory requirement and Digital Transformation.Specialties: QMS | SaaS Quality Platforms (Veeva, Master Control, Track Wise)| GMP/ICH/FDA Compliance | Biologics & Combination Products | CAPA & Risk Management | Digital Transformation | Leadership Development | Regulatory Inspections

Experience

1. Director of Quality

   Biocon Biologics

   Oct 2025 — Present · Bangalore Urban, IN

   I effectively led the Quality strategy at Biocon Biologics, ensuring compliance and operational excellence. • Drove quality governance and managed vendor quality through audits and performance monitoring. • Promoted proactive quality practices and simplification across operational functions. • Reported quality performance and risks to management, representing Quality in cross-functional forums.

Education

• Indian School of Business

  Certificate Masters in Leadership Essentials , Business Administration and Management, General

• Berhampur University

  Master of Science - MS, Analytical Chemistry

• Indian Institute of Management, Lucknow

  Global Senior Leadership Program, Business Administration, Management and Operations

Skills

• Validation
• Gmp
• Sop
• Glp
• Fda
• Hplc
• Quality Assurance
• Capa
• Change Control
• Technology Transfer
• Cleaning Validation
• Lims
• Instrumentation
• V&V
• Quality Control
• Pharmaceutics
• Quality System
• Formulation
• Gas Chromatography
• Analytical Method Validation
• Quality Auditing
• Regulatory Requirements
• Dissolution
• Documentation
• Software Documentation
• Analytical Chemistry
• Regulatory Submissions
• Oos
• 21 Cfr Part 11
• Deviations
• Compliance
• Process Validation
• Stability Studies
• Analytical Methods Development
• Quality System Compliance
• Mhra
• Trackwise
• Standard Operating Procedure (Sop)
• Computer System Validation