Director of Software Validation

Job Summary

To lead the Computer System Validation (CSV) program, the hybrid Director of Software Validation will establish and improve validation processes in compliance with regulatory requirements, while managing a high-performing team and collaborating with cross-functional departments.

Key responsibilities

• Develop and implement a global CSV and CSA strategy aligned with regulatory requirements
• Create validation deliverables, including plans, risk assessments, and protocols, while ensuring robust change control processes
• Serve as the primary subject matter expert for CSV during audits and inspections, leading the remediation of validation-related findings

Required qualifications

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