Samuel Xu

Director-level operations and quality leader with 15+ years across CRDMO/biopharma and life sciences, spanning R&D, quality, production, regulatory, and end-to-end operations across China, Singapore, the EU, and the US. Proven track record delivering measurable growth and scalable execution—driving 78% YoY revenue growth (2024) and 48% growth (2025) while maintaining budget discipline and positive P&L.Recognized for building and leading cross-functional organizations (50+ teams; 100+ orgs) and for sustaining inspection readiness in highly regulated environments, with successful WHO, NMPA, EMA, and FDA interactions, GMP certification outcomes, and repeated top-tier client audits. Deep experience across the product and facility lifecycle, including 30+ IND programs, 10+ PPQ programs, 7 BLAs, and 20+ brownfield/greenfield projects (€600M total) from design through commissioning, qualification, and operational launch, alongside digital transformation initiatives (e.g., EMS/BMS/LIMS) and operational excellence.