Ram Bulusu

Innovative Leader & Proven expert at transforming & scaling healthcare businesses with AI. Innovative Healthcare Digital Leader with a passion for leveraging technology to improve healthcare. Passively seeking Next Gen challenge in BioWearables, Digital Health, IoT, IIoT, IoMT, Gene Therapy, Advanced Medical Devices, Robotic Surgery, Personalized Medicine, Cancer Treatment, Advanced Manufacturing, Responsive Supply Chain, Operations Technology, Intelligent Quality

OVERVIEW Innovator & Inventor of the:
• GoldilocksAi™ risk-based AI Governance Framework
• Gen2Ai™ Second Gen AI powered by industry-first LVM™
• LeanAi™AI-enabled Lean Operations Excellence Program
• GTMx™ Custom GTM model for startups
• i5™ The world’s first Industry 5.0 Model Powered by Gen AI
• AIOT™ AI Enabled Operations Technology
• MASCQOT ™ AI Digital Model
• FLEXICODE ™ Flexible Bio-Manufacturing System
• D3AI ™ AI Digital Strategy for Healthcare Enterprises

Turnaround Expert. Master of Turnkey IT & OT. Entrepreneurial Digital Operations & LEAN Process Transformation Leader with 30+ years of comprehensive Innovation & Execution at progressively increasing levels of responsibility in Pharma, Med Device, Diagnostics, Biotech, Biologics, Gene Therapy, Diabetes & Animal Health industries

LEADERSHIP: Driving digital business transformation across Operations Technology (OT) & IT. Building, leading, managing high-performance Global Lean OT & IT teams. Developing & Executing robust, sustainable strategies for OT, IT, Quality, Manufacturing, Supply Chain, NPI & Clinical. Executing complex global programs & turnarounds. Leading in a hyper-growth business

TECHNOLOGY: Implementing AI/ML enabled global connected enterprise digital solutions across Manufacturing, Supply Chain, Cold Chain, QA, RA, QC, R & D, Clinical, Commercial, & Finance Operations globally (Cobots, Salesforce, Oracle EBS & Fusion, HighJump WMS, SAP, IBP, Model N, Veeva, TrackWise QMS, 123C, MES, SCADA/DCS/PLC, Cloud PLM, Machine Learning, AI, NLP, IoT, Big Data, SaaS, Mobile Health, Cloud, Advanced Analytics, Industry 4.0) & Data Science, GenAI Advanced Prompt Design Engineering

COMPLIANCE: Implementing, enhancing, & maintaining risk-based programs & systems to achieve sustainable FDA regulatory compliance (21CFR Part 820, Part 11, Part 211, ISO13485, e-compliance, CSV, SaMD, GMP, CSV, QSR, SOX, ISO, HIPAA, GDPR, Cybersecurity). Expert at remediating systems under warning letter & FDA consent decree conditions