Qualification and Validation Manager | Qualifizierungs- und Validierungsmanager - BS

Job Summary

The Qualification and Validation Manager will hold overall responsibility for the Computerized System Validation (CSV) and qualification program within the Basel Drug Substance Manufacturing organization. This critical role ensures the continuous qualified status of all relevant biochemical and chemical production plants and systems, working closely with Engineering and Operations. Day-to-day tasks include leading and coordinating CSV and qualification projects, drafting risk analyses, strategies, plans, and reports, and managing changes, deviations, and CAPAs. The manager will also represent validation topics during inspections and within internal and global networks. This position requires a Master's degree in a relevant scientific or engineering field and at least two years of experience in a cGMP-regulated pharmaceutical environment, alongside excellent proficiency in both German and English. It is a highly engaged role focused on maintaining the highest quality standards, which are paramount in this life-science sector.