CMC–PHARMAPILOT

My professional career has touched down in destinations such as GMP Production, Quality Control QC, Quality Assurance QA, Quality Management QM and Chemistry/Manufacturing/Control CMC . While focussing on a wide range of established APIs and NCEs entities from high potent hormones to large volume parenteral (LVP)/contrast media, I also followed my passion for the chemistry of oligonucleotides/peptides.

In addition to that, I have developed a solid set of management skills, as my career route always intersected with management assignments that involved restructuring, due diligences, mergers and other substantial organizational changes.

After starting my career in R&D / Clinical Supplies Manufacturing, I discovered my passion for regulatory topics, quality, process management, and digitalization. I worked in Regulatory Affairs CMC, and later took over responsibility for a global GMP Quality Management System, several IT systems and digital applications with up to 25,000 users, with a focus on document/content management and validation.

I collaborated with development teams as well as with manufacturing sites to establish and maintain compliant regulatory dossiers (modules 2.3 and 3) and ensure a smooth product lifecycle for both chemical and biological entities.