Quality Systems IT Specialist

Legend Biotech is seeking Quality Systems Specialist as part of the US IT team based in Somerset, NJ. 

Role Overview

The Quality Systems Specialist/Admin will be responsible for maintaining various quality and validation applications.

Key Responsibilities  

• IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system (ComplianceWire), validation lifecycle management system (ValGenesis), 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 computer system vendors, IT partners, and the business to coordinate implementation activities.

Requirements

• Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3 to 5 years’ experience
• 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)

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