Quality Systems IT Manager

Job Description

Legend Biotech is seeking a Quality Systems IT Manager to join their IT team in Somerset, New Jersey. This role is crucial for managing and supporting critical GxP computerized systems. The Quality Systems IT Manager will be responsible for the development, enhancement, and support of validated computerized systems that support GxP activities. This position has a significant impact on strategic projects and regulatory compliance within the company.Responsibilities include:

• IT Platform/System leadership and administration for Veeva vaults (Quality, RIM, Clinical).
• Overseeing change management activities.
• Participating in the authoring and execution of computerized system strategies and plans.
• Liaising with software vendors, IT partners, and the business.
• Maintaining validation documentation.
• Managing connections between Veeva platform and Learning Management systems.

Requirements:

• Bachelor’s degree in a Life Science, Information Technology, or a related field (advanced degree preferred).
• Veeva Certification.
• 10+ years of hands-on experience in implementation and support of computerized systems in a regulated GxP environment.
• Experience managing Veeva vaults and platforms.
• Experience utilizing an automated Validation Lifecycle Management System (VLMS).
• Experience with Learning Management Systems (LMS).
• Ability to interpret and apply GxPs, regulatory requirements, CSV, SDLC, and industry best practices.

Legend Biotech offers:

• Opportunity to work on strategic projects.
• A collaborative and positive work environment.
• A chance to contribute to a team-based environment.