Jean-Jérôme DUBUS

Global QA strategy and Transformation for Global pharmaceutical company. Pharmaceutical operations and support in case of special technical situation, recall situation or crisis. Strategic analysis of regulatory situation and solution mapping. Global Corporate regulatory and PV compliance. Worldwide affiliates. Set-up of Manufacturing and Supply Chain business model. Qualified Person. QA RA PV manager for NewCo or startup company. Pharmacien Responsable sections B et C. Pharmaceutical Affairs. Leading the set up of a transversal QA Group operations until the installation of the new Global Quality Head. Manufacturing and Distribution Supply chain Operations. QA interactions Major Pharma's and CDMO and business strategy. Global QA for a network of QP QA manufacturing site managers in EU Management of QA and PV process over EU and worldwide affiliates. Alignment and problem solving strategy. Operational QA. Remediation plan for PAI or after EMA or FDA inspections. National Competent Authorities answerring strategy. Definition of goals, plans for prioritization, execution and control. Team management, alignment and support. Customers support. Remediation plan. CAPA plan. Change Control. Suppliers QA. CMC. Senior Advisor for SME NewCo. Development program of product in front of EMA CHMP. Leading Safety program for registration of breakthrough program in front of FDA.

Consultant for Les Laboratoires Servier. (Suresnes, 92) international french pharmaceutical Company. Role of installation of a Corporate QA Governance over the transversal Head Office functions and affilialtes worldwide. Transformation project team, together with one of Big4 consultancy firms and Transformation office Head.

Consultant for Delpharm Industries SAS. (Boulogne, 92) (Deputy Global QA Director. QA management supporting plant managers and local QA-QP. Compliance QA process CAPA, Change Control and Risk Management. Quality global SOP. GMP audits and inspections. Remediation plans.. Customers satisfaction. Plant QA interim management.

Nanobiotix SA (Paris, F), Regulatory Affairs for CE Mark. (ANSM - Notified Body). Responsible for global QA-QP. Release of bulk products and IMP of Nanoparticles in Oncology. Projects : Platform for manufacturing of MPUP, Design & Build, Qualification. Cleanroom ISO 6, gamma sterilization and filtration technology. Interactions with Clinical team and Safety vigilance reporting. Preparing the GMP up-grade for FDA compliance. Preparing quality system and ICH Q10 for the market launch and Post Market Surveillance. Supply chain construction incl. suppliers qualification and Quality Contracts.

Medical Device industry. 150 FTE. Class 2b and class 3 . Overall compliance and safety (post marketing and clinical) QARA team of 20 FTE. Sterilisation program. Clean room validation. QMS and total quality management. Lean Mfg.

Financial and strategic program. Leadership. External Internship, assesment of the global strategy and acquisition of new technology during executive MBA HEC

Membre de l'APM, Association pour le progrès du management, Amiens. Ensemble de chefs d'entreprises motivés par le succès en Picardie

From Sanofi by buy-out to Pharmygiene and then Omega Pharma. Building ALLOGA France. Logistics platform with multiple services offer. Then sell-out to Galenica with new brand name Alloga. Integrated services to big pharmas ROCHE, TEVA, BAYER and SANDOZ and mid-sizes. Operations management, Site management (200 FTE), Quality System and IT validation, Business development (CMO for 10 leading pharma labs, 1,5 Bio eur). Manufacturing QC. Generics development ROCHE, TEVA, BAYER, GNR Sandoz