Sr. Manager Quality IT

Role: Senior Manager, Quality IT overseeing GxP IT systems within Legend Biotech, ensuring compliance with global regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, GAMP5, and Data Integrity requirements. Responsibilities: provide QA oversight for GxP system lifecycle, validation activities, change management, risk assessment, audit coordination, and regulatory inspection readiness; develop SOPs, validation plans, and system documentation; monitor data integrity and support continuous improvement efforts. Requirements: Bachelor’s in Science, IT, Engineering or related; 10+ years experience in pharma/biotech/medical device industry, including 5+ years leadership; familiarity with GxP regulations, validation tools, LIMS, Veeva, ERP systems (SAP preferred); excellent communication and organizational skills; experience with audits and inspections. Preferred: knowledge of global GxP standards (US, EU, China), clinical GMP/GLP audits. HighValue: expertise in GxP compliance for IT systems supporting cell therapy or biologics manufacturing, validation, audit readiness, and regulatory interactions. WorkSetup: based in Bridgewater, NJ, with minimal travel.