Associate Director, Quality IT

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director, Quality IT as part of the Compliance team based in Somerset, NJ. Role Overview The Associate Director, Quality IT is responsible for leading the IT Quality team and providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems(eSystems) adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines. Key Responsibilities 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 eSystem enhancement and validation activities inclusive of documentation and change controls. Direct and manage the IT Quality Team activities in accordance with compliance and business priorities. Contribute to the development and enforcement of applicable standard operating procedures at Legend. Work with cross functional teams for eSystem 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. Develop, maintain and execute 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 oversight for SOPs governing use and validation of eSystems. Work cooperatively with members of interdepartmental eSystem committees to ensure seamless communication among eSystems. Identify and mitigate risks associated with GxP IT systems and processes, developing strategies to address compliance risks. Train IT personnel and key stakeholders on GxP requirements and standards for computerized systems. Ensure that staff are developed and knowledgeable of regulatory expectations. Support continuous improvement efforts through the monitoring of process perf ... (truncated, view full listing at source)