X4 Life Sciences

CQV Lead

Posted: 2 minutes ago

Job Description

We are seeking an experienced CQV Lead to support our client’s pharmaceutical project in Basel.As the CQV Lead, you will be responsible for leading and coordinating all CQV activities, ensuring full compliance with GMP and regulatory requirements. This role requires hands-on leadership, deep technical understanding of lyophilization processes, and the ability to drive collaboration across engineering, quality, and operations.Key ResponsibilitiesManagement and coordination of C&Q activities across project phasesInterface management between Engineering, Quality, Production, and external partnersCoordination of documentation: creation, review, and approval of C&Q documents including URS, DQ, IQ, OQ, and PQ.Leading C&Q teams an coordinating external service providersPromoting best practices and continuous improvement in CQV methodologies, documentation standards, and project execution.Support FAT/SAT and performance qualification for lyophilizers and associated equipmentRequirementsProven expertise with lyophilizers / freeze-dryers Demonstrated ability to lead CQV teams or manage external partners on complex projects.Excellent communication, coordination, and stakeholder management skillsIdeally German speaking

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