Senior Quality Control Manager - Focus Data Integrity | Biologe (m/w/d)

Job Summary

This critical role is for a Senior Quality Control Manager specializing in Data Integrity at RHEACELL, a biopharmaceutical leader pioneering innovative ABCB5-positive stem cell therapies (ATMPs) in Heidelberg. The manager will be responsible for building and leading the entire Data Integrity program within Quality Control, encompassing strategy development through practical implementation. Day-to-day duties include defining and maintaining data flows, managing audit-trail reviews, overseeing equipment qualification and validation with a strong focus on Data Integrity, and leading investigations, CAPA measures, and SOP creation. The ideal candidate will possess a Master's degree (preferably a PhD) in Biosciences and a minimum of five years of experience in QC/QA, specifically focusing on Data Integrity/CSV within the pharmaceutical sector. This position offers the opportunity to drive medical progress and ensure compliance with stringent FDA and EMA guidelines within a globally active, innovative, and growing company.