Xavier QUANTIN

En résumé

Entreprises

• ProductLife - Senior Consultant / Pharmacist

  2011 - maintenant Clients : Biogaran, Börlind, Cephalon, Eli Lilly, Expanscience, Galderma, Groupe Yves Rocher, Laboratoires Servier, LFB, Sanofi, Stallergènes, Substipharm
  
  Missions:
  − Mid-size company specialized in aesthetic, cosmetics and medical devices: management of the project for implementing a RIM tool and meet IDMP requirements (tool selection, URS, project management, processes description, implementation phase, validation, training phase and go live !)
  − Big-size company specialized in drugs: portfolio analysis and pilot phase for analysing systems and sets of data needed to meet IDMP compliance
  − Mid-size company specialized in vaccines: management of the pre-study phase for selection of a RIM tool / matching with EVMPD / IDMP constraints
  − Mid-size company specialized in drugs: management of the validation phase for implementing the EDM tool (based on Documentum-LSQM) for Regulatory Affairs and Development
  − Small company specialized in generics: management of the project implementing the EDM and eCTD publishing tools (Ennov Doc and Ennov Dossier) for Regulatory Affairs and Development: User Requirements Specifications, Detailled specifications, project and validation management
  − Mid-size company specialized in Allergens: management and writing of the Users Requirements Specifications for Regulatory Affairs tracking tool (RIM) selection, workshops coordination, support for defining product information structure, gap analysis for data migration
  − Mid-size company specialized in aesthetic, cosmetics and medical devices: management and writing of the Users Requirements Specifications for Regulatory Affairs tracking tool (RIM) selection, workshops coordination, management of the migration project from OPX R4 to Planisware P5 used to plan R&D projects and manage budget follow-up in a 500 people R&D unit distributed over 3 sites: project management, definition of adequate processes, Users Requirements Specifications and detailed specifications
  − Mid size company specialized in drugs: management of the XEVMPD submission project, migration from a Regulatory tracking tool to another one
  − Mid-size company specialized in generics: management of the validation phase of the tracking tool (RIM), project leader for Regulatory submission (eCTD) project: validation strategy, actors coordination, planning, business needs specifications, coordination of Product data entry into Regulatory / XEVMPD tool
  − Mid-size company specialized in drugs and cosmetics: business modeling for information management regarding Regulatory Affairs and cosmetic dossiers management
  − Big company specialized in drugs: trainings on Information System validation regarding pharmaceutical regulations (21 CFR Part 11)
  − Big company specialized in cosmetics: project management for identification of raw material providers using adequate choice grid, updates of raw material dossiers – experts management (toxicology expert and regulatory expert)
  − Small company specialized in cosmetics: project management for cosmetic dossiers updates, organization (priorities, risk management) and follow-up – experts management
  − eCTD publishing for several companies
  

• Laboratoires Pierre Fabre - Head of Methodology and IT optimization

  Castres 2009 - 2010 − Security plan for entire Information system, projects lifecycle and documentation management
  − Risks management approach for business processes for entire company in order to define IS priorities
  − IS Sales department process optimization
  − Applicative cartography including business issues
  − IT department processes modeling / comparison between current practices and existing practices (COBIT, Val IT, CMMi)
  − IT department tools management (GED, change control tool)

• Laboratoires Pierre Fabre - Project Manager and Head of R&D – IT systems

  Castres 2006 - 2008 − Application of regulations (GxP) in terms of change management, project management and management of deliverables, contribution to regulatory audits and implementation of quality standard CMMI level 2
  − Project management or project direction for (non-exhaustive):
   eLN project
   scoping phase for SAS project
   scale-up
   IMP tracking project
   Clinical trial data management tool and monitoring tool
  − Pharmacovigilance IS replacement
  − Business assistance in defining major issues (urbanization), scoping phases, suppliers’ selection, specifications.
  − Use of Planisware (OPX2) for ressources and budget management (~700 k€), portfolio management.

• Société Tridem Distri - Responsible pharmacist and CEO

  2005 - 2005 − Information system consolidation and automation for orders and inventory management
  − Good Distribution Practices compliance and quality manager on distribution site
  − Management of a structure for storing medicines for export

• Laboratoires Servier - Project manager – Biometric department

  2000 - 2004 − Business assistance in managing business projects from initial needs to delivery : change control, business processes
  − Good Clinical Practices implementation and management
  − Clinical data standards definition for data collection
  − Links with other business processes (monitoring, IMP management, statistical analysis)
  − Subcontractors audits

Formations

• Université Paris 11 Paris Sud

  Chatenay Malabry 1990 - 1999 Docteur en Pharmacie - DEA de biologie moléculaire
  
  ancien interne des Hôpitaux de Paris
  CESAM option Biologie
  Maîtrise scientifique biologique et médicale (Biochimie et Génétique)
  UVs de maîtrise Biologie et Génétique Appliquée

• Lycée Passy Buzenval

  Rueil Malmaison 1982 - 1990

Réseau

• Aurélien BLANCHON

• Estelle GAROTIN

• Florence DO CARIN

• Grégory RUGET

• Guy CROUZET

• Hélène CARTERON-COTREUIL

• Jean-Alain DEGRAEVE

• Jean-Eric ANCEL

• Orane ROLLAND

• Stéphane PUYOU