Vienna, Vienna, Austria
I lead Quality teams that deliver results — not just compliance. I managed a 109-person quality department where we: - Cut testing time 50% through AI and digitalization - Reduced errors 30% using smart automation - Zero regulatory findings across 15+ global inspections over 10 years 10+ 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.
+ Large scale genetic and pathology research, design and engineering of novel molecular and genetic techniques. PCR, DNA microarrays. Gel electrophoresis, ELISA. + Assay development and maintaining cells/tissues cultures used in pathology research. DNA extraction, sequencing and synthesis. Isolation of enzymes from cells, extraction of proteins from cells, analysis activity of enzymes, enzyme fractionation. Developing antibodies and conjugate for sandwich assays. + Responsible for optimization, verification and validation of Elisa tests. Pathology, tissue culture, virus scanning, Virus detection using immunology methods. + Project management, preparing up-to-date reports and QC as well as GMP assurance. CDFA- Best Product of 2007 in Diagnostic Plant Disease – Cmm PCR kit Novel Enrichment Technique for DNA and RNA Extraction from Plant Tissue- Patented by CALSPL 1 Tube PCR System for Plant Disease Target- Publication in Plant Journal in USA Quantities Detection of Bacterial Pathogens in Seeds by Use of Novel Enrichment Technique Coupled with Real Time PCR- Grant from NSF USA