Neuchâtel, Neuchâtel, Switzerland
Senior Corporate Quality Executive with 25+ years integrating quality across the full product lifecycle, from Manufacturing & Supply Chain (GMP) through Clinical Development (GCP/GVP) to Commercialization (GVP/GDP) & Medical Affairs (GEP). Expert in enterprise QMS strategy, digital transformation, and AI governance, with proven success aligning quality initiatives to global business objectives, financial performance related to Quality, and Culture of Excellence. Harvard-certified in AI Implementation in Healthcare, leveraging next-generation tech (GenAI/LLM/ML) for corporate quality and R&D challenges, including data integrity and risk-based oversight. Key achievements: Reduced redundant vendor Due Diligence Questionnaires by 15% while strengthening data privacy safeguards; reduced major audit findings by 30% and achieved zero critical FDA/EMA/PMDA findings; achieved 100% implementation of critical change controls; led post-$62B Takeda/Shire M&A quality integration.Passionate about patient-centric innovation in BioPharma. Open to connecting on quality leadership, AI in GxP, or opportunities in corporate quality roles. #QualityManagement #AIinHealthcare #BioPharma #DigitalTransformation
Built the end-to-end R&D Quality System enabling successful EU/US biosimilar submissions. Designed integrated GCP/GMP processes ensuring seamless clinical-to-commercial compliance. Achieved 100% implementation of change controls across upstream/downstream processes.
Harmonized QA systems following the Takeda/Shire integration, ensuring continuity across transformed clinical portfolios. Contributed to the global compliance strategy during evolving pipeline and study designs.
Conducted global audits for critical suppliers (CROs, labs, PV) Globally. Reduced major audit findings by 30% and achieved 100% proactive duplicate detection. Supported regulatory inspections ensuring clinical data integrity for vaccine programs (DENVAX).
Led global QA strategy for Clinical Development & Pharmacovigilance. Executed 50+ supplier/study/site audits across US/EU/Japan, improving CAPA effectiveness by 40%. Supported SwissMedic inspections and global rollout of Audit/CAPA systems.
Co-designed the QMS for Pfizer–ICON’s first full-service CRO global partnership. Conducted 60+ vendor audits and supported regulatory inspections for global sponsors. QA lead for strategic partnerships, including integration of acquired entities.