Software Validation Team Lead

Summary

Join Celerion's dynamic team as a Software Validation Team Lead and play a pivotal role in ensuring our IT systems meet the highest regulatory standards. Lead a talented team of validation analysts, testers, and business analysts while driving strategic validation initiatives. This role can be fully remote, ideally working in the Central or Eastern time zone, or willing to work normal business hours in Central time. You will manage a software validation team, develop validation approaches for critical GxP systems, oversee end-to-end validation projects, collaborate with cross-functional teams, and support regulatory inspections. The position offers a blend of technical challenge and leadership opportunity, allowing you to shape validation strategies while working with cutting-edge IT systems.

Requirements

• Education : Bachelor's degree in computer science, health sciences, or equivalent experience in pharmaceutical/clinical settings
• Experience : 5+ years in software validation within GxP environments, plus 3+ years of line manager experience
• Expertise : Strong knowledge of 21 CFR Part 11, GMP/GLP/GCP requirements, and validation best practices
• Skills : Exceptional communication, problem-solving, and organizational abilities

Responsibilities

• Lead & Inspire : Manage a dedicated software validation team of 6 and guide them to success
• Drive Strategy : Develop validation approaches for critical GxP systems and ensure compliance with GAMP principles and 21 CFR Part 11
• Deliver Results : Oversee end-to-end validation projects, from planning through execution and reporting
• Collaborate : Work closely with IT, QA, and cross-functional teams to deliver compliant systems
• Represent Excellence : Support regulatory inspections and sponsor audits with confidence

Benefits

This role can be fully remote, ideally working in the Central or Eastern time zone, or willing to work normal business hours in Central time