GxP Software Validation Lead

Job Summary

A company is looking for a Software Validation Team Lead to ensure IT systems meet regulatory standards.

Key Responsibilities

• Manage and guide a software validation team of 6
• Develop validation approaches for GxP systems in compliance with GAMP principles and 21 CFR Part 11
• Oversee end-to-end validation projects, collaborating with IT, QA, and cross-functional teams

Required Qualifications

• Bachelor's degree in computer science, health sciences, or equivalent experience in pharmaceutical/clinical settings
• 5+ years of experience in software validation within GxP environments
• 3+ years of line management experience
• Strong knowledge of 21 CFR Part 11 and GMP/GLP/GCP requirements