Lausanne, Vaud, Switzerland
Specialties: Quality Management, Pharmaceutical Technical Operations, Biologics, Gene Therapy, Supply Chain, Third Party Manufacturing, CMC project management, Inspection Readiness, Clinical Operations, Quality Systems and Performance, GMP, GDP, GVP, GCP
Supported client’s FDA inspection readiness effort. BLA approved in 2022.
- Led the FerGene Quality Unit. Built and managed a team of Quality professionals. - Designed and implemented best-in class Quality Systems and Operations for clinical development, virtual manufacturing and distribution, commercial supply and post-marketing surveillance for a Gene Therapy Product with indication in uro-oncology. - Quality oversight and risk management for BLA and inspection readiness. - Quality support to clinical program .
- Developed and led the global Quality teams responsible for external manufacturing operations (ca 30 CMOs), supply chain compliance and in-country (>40 affiliates) quality oversight. - Member of the GQA Executive Leadership Team - GQA representative at corporate Business Flow Committee. - Supported due diligence and QA implementation of in-licensed products - Global responsibility over FERRING product release process, global product complaints review - Supported SVP GQA in the management of critical situation and coordinate product recall execution.
- GQA oversight and support for assigned manufacturing sites EU & FDA approved (API chemical, biotech, sterile drug products with aseptic processing, solid dosage forms) - Led PAI readiness project, quality audits, due diligence. - Supported SVP GQA for critical situations management. - Developed global Quality Standards. - Member of Ferring QbD project team.
Provided support to manufacturing sites, Led international Quality projects for Manufacturing Compliance.