Kat Klodzinska
Global Director- Quality, Vigilance and Environment @Linde
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WORK HISTORY
Global Director- Quality, Vigilance and Environment @Linde
As a senior leader in global quality and compliance, I lead cross-functional initiatives that elevate standards across Pharmacovigilance, Environmental, and Quality systems. With a strong command of global regulatory frameworks—including FDA, EMA, and MHRA—I ensure enterprise-wide alignment with GxP, ISO, and Responsible Care principles. Pharmacovigilance & QMS LeadershipLead the global PV Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 210/211, EU GMP, EMA, and MHRA regulations.Oversee root cause analysis (RCA) for high-severity incidents and drive improvements in signal detection, incident reporting, and medical reconciliation.Coordinate global Medical Device Reporting (MDR) activities and ensure inspection readiness. Environmental StewardshipDirect global environmental incident reporting and sustainability metrics analysis.Lead remediation projects and support ESG goals through data-driven environmental strategies. Quality ExcellenceDefine and implement Linde’s global quality strategy, embedding GMP and GVP frameworks.Govern supplier quality and lead the global Medical Validation Program.Champion food-grade gas compliance aligned with ISO and local food safety authorities. Responsible Care & Systems IntegrationCoordinate the global Responsible Care program, aligning standards into a cohesive system for local execution.Manage digital platforms (SharePoint, Teams) and enhance global team agility and responsiveness. Capability Building & TrainingDesign and deliver global training programs across Quality, Environmental, and PV domains.Build regional and local capabilities through targeted development initiatives. Strategic LeadershipChair global forums including Quality COP and GET, and lead succession planning for key functions.Communicate strategic direction, manage global reviews, and engage teams through international travel.Oversee global budgets and ensure optimal resource allocation.
EDUCATION
University of Bath
Executive MBA
Politechnika Śląska w Gliwicach
Master of Science (MS), master of engineering
CQI quality management
Diploma
ABOUT KAT KLODZINSKA
Quality and Environmental “Katalyst” for Excellence! Driving quality excellence…
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