Jobs → Customer Support → Lead Cloud Qualification / CSV Architect

About the Role We are seeking an experienced Lead Cloud Qualification / CSV Architect to lead cloud infrastructure validation and Computerized System Validation (CSV) activities within a regulated pharmaceutical or life sciences environment. The ideal candidate will have strong experience in GxP compliance, cloud qualification, AWS/Azure infrastructure, and regulatory validation processes. Key Responsibilities • Lead cloud qualification and Computerized System Validation (CSV) activities across enterprise cloud environments. • Develop and execute cloud validation strategies, plans, and qualification protocols. • Perform GxP risk assessments and identify compliance gaps. • Lead qualification of AWS and Azure cloud infrastructure, platforms, and services. • Review cloud architecture, configurations, security controls, and infrastructure documentation. • Ensure compliance with FDA 21 CFR Part 11, GAMP 5, GxP, and other applicable regulatory requirements. • Prepare and review validation documentation, including: - Validation Master Plans (VMP) - User Requirements Specifications (URS) - Functional Specifications (FS) - Risk Assessment Documents - Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ) • Maintain validation evidence, test results, deviations, and CAPA documentation. • Collaborate with Cloud Engineers, Infrastructure Teams, QA, IT, and Compliance teams. • Provide technical leadership and guidance to validation and qualification teams. • Support internal and external audits and regulatory inspections. Requirements • 8+ years of experience in Computerized System Validation (CSV) or Computer System Assurance (CSA). • Strong experience in pharmaceutical, biotechnology, or life sciences environments. • Hands-on experience with AWS and/or Azure cloud infrastructure qualification. • Strong knowledge of GxP, GMP, GAMP 5, and FDA 21 CFR Part 11. • Experience with cloud validation and qualification documentation. • Knowledge of IT infrastructure, networking, security, and cloud architecture. • Experience in risk-based validation methodologies. • Strong understanding of SDLC and validation lifecycle processes. • Excellent communication, documentation, and stakeholder management skills.