Software Program Manager

Job Summary

A company is looking for a Software Program Manager to oversee regulatory software systems in manufacturing.

Key Responsibilities

• Coordinate planning and execution of regulated IT capabilities to enhance manufacturing and quality operations
• Collaborate with developers and quality teams to provide technical direction on software requirements, design, and deployment
• Ensure compliance with cGMP, FDA, and other regulatory requirements throughout the software lifecycle

Required Qualifications

• 4-year college degree with 4-8 years of related experience or equivalent combination of education and experience
• Experience in an FDA regulated environment and familiarity with Quality Management processes
• Knowledge of computerized software development and validation life cycle
• Experience with various software systems including Quality Management and Laboratory Information Management
• Proficiency in project management tools and methodologies