CSV/CSA Validation Transformation Consultant

Role overview

Lead client assessments and implement risk-based validation and software assurance frameworks for regulated computerized systems. Modernize validation practices while maintaining appropriate evidence, quality oversight and controls for patient safety, product quality and data integrity.

Key responsibilities

• Assess current CSV practices and develop a prioritized transformation roadmap.
• Design risk-based assurance frameworks, SOPs, templates and governance with client Quality and system owners.
• Define intended use, assess risks and select appropriate scripted, unscripted or automated testing; review evidence and resolve deviations.
• Develop and review proportionate validation/assurance plans, requirements, risk assessments, traceability and summary reports; approve only where formally authorized.
• Assess suppliers and assurance needs for SaaS releases, integrations, upgrades and data migrations.
• Lead pilots, train teams, support audit readiness and mentor junior consultants.
• Measure agreed improvements in validation effort, review time and rework.

Essential qualifications and skills

• Bachelor's or Master's degree in Life Sciences, Pharmacy, IT, Computer Science, Engineering or a related discipline.
• 8-10 years of relevant CSV/GxP experience, including technical leadership, and at least 3 years of consulting or equivalent stakeholder advisory experience.
• Demonstrated delivery of risk-based validation modernization or CSA initiatives.
• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, change control and FDA CSA guidance applicability.
• Hands-on validation experience with one or more clinical, safety, quality, laboratory or manufacturing platforms, such as EDC, Veeva Vault, Argus, TrackWise, LIMS, MES or SAP.
• Strong documentation, stakeholder communication and workshop facilitation skills.

Preferred

Relevant CSV/CSA training or certification; experience with SaaS/cloud assurance, digital validation tools and test automation.

Regulatory scope

Apply FDA CSA guidance within its medical-device production and quality management system scope. For other GxP systems, justify risk-based assurance against applicable requirements and client procedures; validation obligations remain applicable