CSV/CSA Expert

We are seeking an experienced CSV / CSA Validation Lead to drive the transition from traditional validation approaches to risk-based Computer Software Assurance within a regulated pharmaceutical environment. You will define validation strategies for cloud and SaaS platforms, guide delivery teams in adopting CSA practices, and ensure compliance while reducing unnecessary testing and documentation.

Key Responsibilities

Lead the transition from traditional CSV practices to a risk-based CSA approach across configuration, integration, and QA teams. Define validation and testing strategies aligned with GAMP 5, FDA CSA guidance, 21 CFR Part 11, and EU Annex 11. Guide risk assessments to determine appropriate testing scope, evidence, and documentation. Oversee validation activities for cloud and SaaS platforms used within GxP environments, including Veeva Vault where applicable. Partner with QA and test automation teams to align automated test coverage with risk assessments and compliance requirements. Act as the validation subject matter expert during regulatory inspections and audits. Influence stakeholders and coach delivery teams to embed CSA principles into everyday delivery practices. Identify opportunities to streamline validation without compromising quality, data integrity, or compliance.

Requirements

Strong hands-on experience in Computer System Validation, with demonstrated leadership in transitioning teams from CSV to CSA. Deep knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11. Experience defining and implementing risk-based validation and testing strategies. Experience validating cloud or SaaS platforms in a GxP-regulated environment. Experience supporting regulatory inspections or audits as a validation SME. Strong stakeholder management, influencing, and communication skills. Experience working with QA and test automation teams to make risk-based test coverage decisions. Eight or more years of relevant experience is preferred, but candidates with fewer years and strong practical expertise will also be considered. Veeva Vault validation experience is strongly preferred.

Benefits

Prague

• Smíchov Contract Type: Freelance / Contract Start date: October, 2026 Time Allocation: 40 hours/week Global Pharmaceutical Company in Prague