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Quality Systems IT Manager

Somerset, New Jersey, United States
Legend Biotech is seeking a Quality Systems IT Manager as part of the IT team based in Somerset, NJ. 

Role Overview

 The Quality Systems IT Manager is responsible for the system and platform-level management and support of critical GxP computerized systems. This role will take ownership of the development, enhancement, and support of validated computerized systems which support GxP activities and is a critical role in the company with significant impact on strategic projects and regulatory compliance.

Key Responsibilities  

  • IT Platform/System leadership and administration for Veeva vaults (Quality, RIM, Clinical).
  • Oversee change management activities in support of operations, expansion and optimization of use, business customer requirements, and vendor releases and enhancements.
  • Participate in the authoring and execution of computerized system strategies, plans, and validation deliverables.
  • Liaise with software vendors, IT partners, and the business to coordinate support, enhancement, and implementation activities.
  • Own, review, approve, and maintain validation documentation and deliverables utilizing the automated validation lifecycle management system in an inspection-ready state.
  • Manage connections, interactions, and workflows between Veeva platform and Learning Management systems and processes.

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 regulated GxP environment within the biotech or pharmaceutical industries.
  • Management of implementation, development, and support of Veeva vaults and platform.
  • Experience utilizing an automated Validation Lifecycle Management System (VLMS). Docusign Envelope ID: D907D986-C54C-4A38-9332-C3DF9BF3C4ED
  • Experience with one or more computerized Learning Management Systems or platforms (LMS).
  • Ability to interpret and apply GxPs, regulatory requirements, Computer Systems Validation (CSV), SDLC, and industry best practices.
  • Experience in GxP, particularly as it applies to Cell Therapy or Biologics manufacturing, Quality, and automated systems, a plus.
  • Demonstrated experience leading and executing IT operations support and enhancement projects.
  • Ability to take initiative and prioritize objectives from multiple complex projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team, and proactive initiative in resolving problems and developing recommendations.
  • 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.
  • Self-directed with a high degree of professional integrity, very organized, and detail-oriented.
  • Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word), IT Management platforms (ServiceNow, JIRA), and/or other relevant software programs.
  • Veeva Platform and (various) Vault management, with certification.
  • Knowledge and understanding of GxP regulations and their impact on CSV.
  • Knowledge of Data Integrity principles, 21 CFR Part 11, Annex 11, and GAMP.
  • Experience in applying risk-based methodologies.
  • Familiarity with use of electronic systems for Quality Management (QMS), Validation Lifecycle Management (VLMS), and Document Management.

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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.

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