Quality Systems IT Manager

Quality Systems IT Manager

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).
• 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.

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.

Preferred Qualifications

• Advanced degree preferred.
• Experience in GxP, particularly as it applies to Cell Therapy or Biologics manufacturing, Quality, and automated systems, a plus.