Director of Software Validation

Job Summary

A company is looking for a Director, Software Validation.

Key Responsibilities

• Develop and implement a global Computer System Validation (CSV) and Computer Software Assurance (CSA) strategy
• Ensure compliance with regulatory requirements and lead organizational readiness for evolving standards
• Build and lead a high-performing validation team while collaborating with cross-functional departments

Required Qualifications

• Bachelor's or Master's in Computer Science, Engineering, or Life Sciences
• Minimum 10 years of progressive CSV experience in a GxP-regulated environment
• Expertise with GAMP 5, 21 CFR Part 11, and FDA Data Integrity guidance
• Strong knowledge of GMP, GCP, GLP, and ICH E6
• Experience managing cross-functional global validation programs