Hiro Maruyama

Background

About Hiro Maruyama

Operations executive with extensive experience in global pharmaceutical manufacturing, currently serving as Vice President and Head of Operations for the Japan Plasma New Facility Program at Takeda. Focused on delivering startup of an end-to-end plasma manufacturing operations. With a career spanning 30 years, contributes deep expertise in drug product manufacturing, including aseptic formulation, sterile filling, visual inspection, and packaging. Committed to advancing operational capabilities and supporting regulatory compliance to deliver sustainable performance in complex pharmaceutical operations. CORE EXPERTISE • Site leadership & P&L governance for 24/7 aseptic fill–finish operations • End-to-end drug product: formulation, sterile filling, lyophilization, visual inspection (automated vision), and packaging across vial, cartridge, and pre-filled syringe platforms • Tech transfer & validation (OQ/PQ/PPQ, APS), QbD, and process control strategies • Quality systems & cGMP compliance; inspection readiness and multi-agency approvals • Lean / Six Sigma, problem solving, and continuous improvement • Digital & automation: production scheduling, MES/integration, and analytics • Matrix leadership, talent development, and cross-functional stakeholder engagement