Lead Validation Specialist

A company is looking for a Lead Validation Specialist to oversee validation initiatives in compliance with regulatory standards.

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

Strong technical foundation with relational databases (Oracle, MS SQL)