About the role
Role overviewLead client assessments and implement risk-based validation and software assurance frameworks forregulated 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 andsystem owners.- Define intended use, assess risks and select appropriate scripted, unscripted or automated testing; reviewevidence 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 arelated discipline.- 8-10 years of relevant CSV/GxP experience, including technical leadership, and at least 3 years ofconsulting 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 FDACSA guidance applicability.- Hands-on validation experience with one or more clinical, safety, quality, laboratory or manufacturingplatforms, such as EDC, Veeva Vault, Argus, TrackWise, LIMS, MES or SAP.- Strong documentation, stakeholder communication and workshop facilitation skills.
PreferredRelevant CSV/CSA training or certification; experience with SaaS/cloud assurance, digital validation toolsand test automation.
Regulatory scopeApply FDA CSA guidance within its medical-device production and quality management system scope. Forother GxP systems, justify risk-based assurance against applicable requirements and client procedures;validation obligations remain applicable