GxP Manufacturing Applications Manager

Job Summary

Managing end-to-end GxP regulated manufacturing systems, the full-time salaried GxP Manufacturing Applications Manager will ensure compliance, oversee system performance, and coordinate with cross-functional teams in a fully remote capacity.

Key responsibilities

• Own the lifecycle management of GxP manufacturing systems, including planning, enhancements, and decommissioning
• Ensure compliance with GxP regulations and internal quality standards, maintaining inspection-ready documentation
• Coordinate with the Validation team for change management and oversee operational stability and performance of GxP systems

Required qualifications

• Bachelor's degree in Information Technology, Engineering, Life Sciences, or a related discipline
• At least 4 years of experience managing manufacturing IT systems in regulated environments
• Strong understanding of manufacturing systems such as MES, LIMS, and QMS
• Experience with IT service management and quality governance processes
• Hands-on software development experience with technologies such as C#, JavaScript/TypeScript, and API integrations