Manager of Validation and Testing

Job Summary

Leading the transition to automated testing, the full-time Manager of Validation and Testing will oversee software quality assurance and validation frameworks for GxP and non-GxP systems while ensuring compliance with regulatory standards.

Key Responsibilities

• Drive the shift from manual to automated testing, implementing scalable frameworks and integrating them into SDLC pipelines
• Oversee risk-based validation for cloud platforms and databases, ensuring compliance with regulatory guidance and maintaining audit readiness
• Lead end-to-end testing processes, collaborating with development teams to resolve defects and optimize delivery schedules

Required Qualifications

• Bachelor's Degree in a relevant field
• 8+ years of experience in CSV/software testing, with at least 5 years in leadership roles within QA or validation teams
• Proven industry experience in pharma, biotech, medical devices, or CRO environments
• Hands-on expertise in scaling automated testing frameworks and working with relational databases (SQL Server/Oracle)
• Deep understanding of ALCOA+, risk-based validation methodologies, SDLC, and Agile practices