What are the responsibilities and job description for the Quality Systems IT Manager position at legendcareers?
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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