(Senior) Quality Manager (m/f/x)

primary contact for all quality related topics;

manage the quality oversight at the CMOs;

support other DS functions as an expert in quality topics and processes;

responsible for quality related topics like change control, deviations, complaints related to DS products at CMOs;

Define effective CAPAs and track the timely implementation;

review, evaluate and approve documents like APQRs, PPQ reports or CPVs;

responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work;

 support CMOs during Authority Inspections and perform audits;

identify quality risks at our CMOs;

identify and define quality needs for CMOs;

share quality related information from the CMOs to global stakeholders;