Güttingen, Thurgau, Switzerland
That´s me: Diploma Biologist and certified Ecotoxicologist working for 20 years in quality, regulatory, and science. I am committed to compliance and safety across the pharmaceutical, chemical, and medical device industries. Professional Expertise: I specialized in the establishment and management of Quality Management under GxP (GLP, GMP, GDP, ISO 17025, 13485, 9001) and global registration/notification/authorisation. I am certified as Responsible Person (RP) including narcotics (Fachtechnisch verantwortliche Person/ FvP & Verantwortliche Person Betäubungsmittel/VP). I lead initiatives in: • QMS: (Re)establishing robust frameworks from scratch • AI integrating into SOP governance: authoring, evaluation, and verification of processes to enhance efficiency and accuracy. • Risk & Compliance: Conducting FMEA analysis, managing deviations and CAPA, and leading internal and external audits for compliance with applicable legislation and standards. Leadership & Reg Affairs: • Strong background in global substance legislation (Swiss HMG, AMBV, BetmKV, ChemG, EU REACH, BPR, CLP, US TSCA) • Successful managing large-scale dossiers and test strategies for the US, EU, and Swiss markets. • Project Leadership: Managing global submissions with budget responsibility and overseeing consortia for major chemical dossiers. • Consulting: Advising on global substance law and compliance strategies and providing expert opinions on ecotoxicology and Endocrine Disruptive (ED) assessments for key global clients. • Advocacy: Served as the Chair of an employee representative body for 850 colleagues. Personal engagements: I believe in community service and education, having served as a volunteer firefighter and as a biology teacher. Languages: German (Native), English (Business Fluent), French (Basic).
Quality lead for narcotics in a fast growing pharma sector.
Qualified Person dep. (stv. FvP), and Responsible Person narcotics
All around chemical registrations and notification worldwide under various legislation, besides ecotox assessments and project management
• REACH, CLP-, Biocidal- and Plant Protection Product-Regulation • Endocrine Disruptive & Environmental Risk Assessment, PBT/vPvB , UVCB, mixture & metals • QSAR and Read Across including categorisation, inter- and extrapolation • IUCLID, CHESAR, ECETOC-TRA, EUSES • Consortium work • Project management
• REACH, CLP-, Biocidal- and Plant Protection Product-Regulation • Endocrine Disruptive & Environmental Risk Assessment, PBT/vPvB , UVCB, mixture & metals • QSAR and Read Across including categorisation, inter- and extrapolation • IUCLID, CHESAR, ECETOC-TRA, EUSES • Consortium work • Project management • Client recruitment