Vienna, Vienna, Austria
Most quality systems are built for the scenarios someone already thought of. My job is usually what happens in the scenario nobody wrote a procedure for. I've spent my career in the space between standards — GMP, ISO, ICH Q9(R1) — where the rulebooks technically agree but the practical answer isn't written anywhere. That's where I work best: building risk frameworks that hold up under real inspection pressure, not just internal audit. My background includes Head of QC leadership across multiple countries for plasma products and biosimilars, GMP inspection readiness across FDA, EMA and other multi-authority environments, and hands-on QRM architecture work — from redesigning incompatible risk-scoring methodologies to building deviation impact frameworks that actually change decisions on the floor, not just the paperwork behind them. I've implemented LIMS and TrackWise systems, worked across biologics and sterile injectables, and built quality risk management programs from the ground up more than once. I write here about the gaps that don't show up in a gap analysis — where compliance is technically satisfied and the actual risk isn't, and what it takes to close that distance before a regulator finds it first. 11+ years transforming pharma quality operations through innovation and leadership. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ MY APPROACH: TEAMS THAT THINK WITH AI, NOT LIKE AI I believe the future of pharma quality is human intelligence amplified by technology. I implement AI and digital tools that eliminate repetitive work — freeing quality professionals to focus on strategic thinking, risk management, and continuous improvement. Result: Teams that work smarter, faster, and deliver measurable business impact. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ EXPERTISE: Quality Leadership: QC | QA | Compliance | Quality Systems | GMP Digital & AI: Smart automation | Predictive analytics | Process digitalization Regulatory: FDA | EMA | AGES | Health authority inspections | Audit readiness Systems: CAPA | Deviation management | Change control | Risk management | Supplier quality Technical: Analytical methods | Validation | Laboratory systems
+Develop a risk based strategy for the Assay Transfer +Develop the master Transfer plan and integrated Project plan +Coordinates and assures the successful Transfer +Supports Trouble Shooting
+ Contributed to research and development of a patented technologies which is now used in commercial available NGS library preparation kit ( SENSE) + I was also responsible for optimization, verification and validation of molecular biology tests. + I gained experience and became an expert in molecular biology, DNA and RNA amplification - PCR (multiplex, RT-PCR, digital PCR). + Contributed to the development of solid phase markers and selective amplification of nucleic acids attached to solid phase + Large scale preparation of in vitro transcript, quality assurance and quantification.