pAre you an experienced CSV and CQ professional who can bring together Quality, IT, OT, and Engineering teams to deliver a seamless validation framework from start to finish? /ppProclinical is seeking an E2E CSV/CQ Lead to oversee and deliver an integrated qualification and validation strategy for a key project. This role involves developing a modular, risk-based approach to ensure compliance and operational readiness across various systems, integrations, and applications. You will work closely with cross-functional teams to align on validation frameworks and ensure all deliverables meet quality standards. /ppPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /ph3Responsibilities /h3ulliDevelop and maintain an integrated Computer System Validation (CSV) and Commissioning Qualification (CQ) strategy for the project. /liliDefine intended use, GxP boundaries, system classifications, and validation principles across source systems, integrations, platform services, data products, and operational applications. /liliCoordinate execution of qualification and validation activities for production deployment. /liliEnsure complete requirements traceability, testing, validation evidence, data integrity, and release readiness across the end-to-end solution. /liliCollaborate with Business, Engineering, Automation, IT-OT, Semantic, and Application workstreams to ensure alignment and delivery. /liliDefine qualification approaches for operational applications such as batch traceability, process monitoring, and customer data sharing. /liliAssess and verify data integrity, ALCOA compliance, auditability, and data lineage across connected systems. /liliDevelop reusable validation blueprints, strategies, and archetypes for future deployments. /liliFacilitate risk assessments, intended-use evaluations, and validation decisions across stakeholders. /liliEnsure supplier assurance, validation governance, and validated-state maintenance requirements are met. /liliDrive a pragmatic, risk-based, and scalable validation approach that balances compliance, operational needs, and scalability. /li /ulh3Key Skills and Requirements /h3ulliProven experience in developing and coordinating validation strategies for integrated systems spanning IT, OT, data platforms, and operational applications. /liliStrong understanding of risk-based validation principles, including intended use, GxP impact, and system criticality. /liliBroad knowledge of automation, MES, historians, infrastructure, integration platforms, enterprise applications, and their validation implications. /liliExperience validating data flows, transformations, interfaces, contextualization logic, data products, and software applications in regulated environments. /liliExpertise in requirements development, traceability matrices, risk assessments, testing strategies, and controlled validation documentation. /liliPractical experience with data integrity, ALCOA principles, and assessing data lineage, transformations, and auditability. /liliFamiliarity with supplier capabilities, vendor documentation, and qualified platform services. /liliStrong knowledge of GMP, CSV-CSA, CQ, controlled change, deviations, CAPA, and validated-state maintenance. /liliAbility to align cross-functional teams, including Business, Quality, IT, OT, Engineering, and external partners, around a coherent validation approach. /liliLeadership skills to establish compliant and defensible validation strategies without unnecessary documentation or duplicated efforts. /li /ul #J-18808-Ljbffr
E2E CSV/C&Q Lead Arbeitgeber: ProClinical
Proclinical ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten im Vertrieb im Gesundheitswesen voll entfalten können. Mit einem starken Fokus auf Teamarbeit und persönlicher Entwicklung fördert das Unternehmen eine Kultur des Wachstums und der Exzellenz, während es gleichzeitig die Einhaltung ethischer Standards und gesetzlicher Vorschriften sicherstellt. Die Position des National Sales Manager in Deutschland bietet nicht nur die Möglichkeit, einen bedeutenden Einfluss auf den Markt auszuüben, sondern auch Zugang zu umfangreichen Ressourcen und einem Netzwerk von Fachleuten, die sich leidenschaftlich für die Verbesserung der Gesundheitsversorgung einsetzen.
