Responsibilities: This CSV Lead will be working with the application configurators to document the processes and workflow. Identifying risks-based approach to their validation process; future enhancements, upgrades, workflow mods, etc. This will be a cloud-based system. PQ will be the focus for the validation process and policies. Someone coming out of small to mid-size co is ideal for this role. Familiarity with IDOL IT concept (systems governed across a number of processes), change controls, backup and restore, disaster recovery, business continuity plan, etc. Risk based approach to candidates work how to apply risk as it relates to CSV. Some working experience using CSA approach. System risk assessment understand risk as it applies to products, patients and quality. Requirements: Experience validating Veeva applications. Experience validating integrations from lab equipment. Ability to work independently and manage timelines. Ability to work with demanding stakeholders. Digital comp systems oversight supporting supply chain (GxP principles looking for GMP). Audits and change controls. Involved with periodic system review mini audits. The client is implementing many cloud and on-prem applications. Experience in 21CFR Part 11 audit trails and access management. Familiarity with audits and periodic reviews oversight functions to monitor systems while in operations (audit software providers change management). J-18808-Ljbffr