Quality Systems IT Manager

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.

Requirements

• Bachelor’s degree in a Life Science, Information Technology, or a related field.
• 10+ years of hands-on experience in implementation and support of computerized systems in regulated GxP environment within the biotech or pharmaceutical industries.
• Experience utilizing an automated Validation Lifecycle Management System (VLMS).
• Veeva Certification.
• 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.
• 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.
• 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.

Benefits

• Drug-free workplace
• Equal employment opportunity
• Affirmative action employer
• Diverse and inclusive workforce