Hiring: Sr. Manager Quality IT Company: Legend Biotech Location: Bridgewater, NJ Job Posted Time: 2026-09-10 18:08:04 Target Skills & Keywords : Compliance, GCP, SAFe About the job Required Skills: •Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements. •Provide IT Quality oversight for GxP System enhancement and validation activities inclusive of documentation and change controls. •Contribute to the development and enforcement of applicable standard operating procedures at Legend. •Work with cross-functional teams for System upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance. •Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices. •Maintain master files, profiles and tables for multiple software applications and drive harmonization across systems. •Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met. •Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes. •Support and maintain the annual IT supplier audit program. •Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures as well as with all applicable regulatory requirements. •Provide Quality o Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!