GxP Software Validation Lead

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

Jun 12, 2025 - 16:40
 0
GxP Software Validation Lead
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