Manager, Manufacturing Applications

This is a fully remote position, open to applicants in Iowa, +1 more state.

📋 Description

• Take full responsibility for the comprehensive management of GxP-regulated manufacturing systems.

• Ensure that manufacturing systems function in accordance with GxP regulations.

• Collaborate with the Validation team and oversee change management for GxP systems.

• Work closely with Quality, Manufacturing, and IT stakeholders to convert operational requirements into compliant system functionalities.

• Supervise the operational stability and performance of GxP systems.

• Manage vendors and service providers supporting GxP systems.

• Maintain documentation that is ready for inspection, and assist with internal and external audits as well as regulatory inspections.

⛳️ Requirements

• A Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a related field.

• A minimum of 8–10 years of experience in supporting or managing manufacturing IT systems within regulated environments.

• Proven experience in managing GxP-regulated systems, including validation support, compliance oversight, and change control in collaboration with Quality and Validation teams.

• Strong knowledge of manufacturing systems (e.g., MES, LIMS, QMS, instruments related, or similar manufacturing platforms).

• Experience in IT service management and quality governance processes.

• Practical software development experience supporting system integrations, automation, or platform enhancements, utilizing technologies such as C#, JavaScript/TypeScript, modern web frameworks (e.g., React), and API-based integrations.

🏝️ Benefits

• Paid time off

• Medical/dental/vision insurance

• 401(k) for eligible employees

• Remote work arrangement