Lead Validation Specialist

Job Summary

A company is looking for a Lead Validation Specialist to lead validation initiatives in compliance with GxP regulations.

Key Responsibilities

• Lead and manage the validation team to ensure compliance with GxP and 21 CFR Part 11
• Develop, execute, and maintain validation strategies and documentation for clinical systems
• Collaborate cross-functionally with developers, QA, and SMEs to support validated environments

Required Qualifications

• Bachelor's degree required
• 8+ years of professional experience in computer systems validation within life sciences or clinical research
• 5+ years leading a validation team or similar function
• Proven expertise with GxP and 21 CFR Part 11 compliance
• Experience with SDLC, Agile methodologies, and validation of cloud-based systems