Director, QA Validation & Computer Systems Assurance

A Director of QA Validation at Regeneron leads the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for a highly automated biopharmaceutical manufacturing site. The role involves developing risk-based qualification strategies, managing validation lifecycles for complex systems like MES and LIMS, and representing the organization during regulatory inspections. This position requires leading a team of validation scientists and engineers while ensuring compliance with FDA, EMA, and ICH guidelines.