Senior Scientist, Post Market Quality (PMQ) | Senior Scientist PMQ (m/w/d)

Job Summary

This Senior Scientist role within Global Quality and Regulatory at Roche Diagnostics focuses on managing and resolving complex post-market quality issues, specifically handling non-routine technical inquiries and customer complaints related to Custom Biotech and NAP/qPCR products (Lightcycler and MagnaPure). The professional will be responsible for the timely processing, investigation, and documentation of cases according to ISO quality standards, FDA regulations (21 CFR 820.198), and internal quality management systems (mQMS). Key tasks include designing experimental investigations, performing statistical data analysis to identify potential product problems, initiating Corrective and Preventive Actions (CAPAs), and collaborating globally with R&D, Operations, and Regulatory teams to ensure appropriate actions are derived from case findings. This position requires strong scientific acumen, regulatory knowledge, and excellent communication skills, with a mandatory 50% presence at the Penzberg site.