Quality Systems IT Specialist

Company Information 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 and natural killer (NK) cell-based immunotherapy. 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) in 2017. 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 Quality Systems IT Specialist as part of the US IT team based in Somerset, NJ. Role Overview The Quality Systems IT Specialist will be responsible for maintaining various quality and validation applications. Key Responsibilities Support IT System Administration in Veeva vault (Quality, RIM, Clinical), learning management system (ComplianceWire), and electronic signature systems (DocuSign). Perform change management activities in support of vendor enhancements and customer requirements. Participate in the authoring and execution of computerized system validation documentation. Liaise with leaders in the Quality Systems team, computer system vendors, IT partners, and the business to coordinate support activities. Requirements Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3 years' experience preferred Minimum 1 year of experience supporting quality IT systems preferred Experience managing and administrating quality IT systems in a GxP environment Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs Demonstrated ability to work independently to complete assignments within defined time constraints Ability to interpret and apply GxPs, regulatory requirements, Computer Systems Validation (CSV), SDLC, and industry best practices Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail-oriented Strong interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations Experience with the following systems preferred: CompliaceWire, etc.), Validation Lifecycle Management System (ValGenesis, HP ALM, etc.), Change Control/Management, Document Management Systems (Veeva, Documentum, etc.), Electronic Signature System (DocuSign), IT demand/system/support Management (ServiceNow, Polaris) #LI-JK2 #LI-Hybrid Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug-free workplace.

Created: 2024-11-05