- Head of Global Quality System and Head of Global Quality & Compliance Manufacturing Sites. chez Meri
2012 - maintenant
Define & deploy the Quality Policy across MERIAL through the implementation and monitoring of Quality Systems, based upon Sanofi, Merial & regulatory requirements.
Manufacturing Quality & Compliance mission is to lead and coordinate Quality and Compliance within all Industrial Sites to ensure that all products are developed and manufactured in compliance with the company and regulatory requirements
- Global Biology Quality Assurance & System Support Director / Global Quality & Biosafety
2006 - 2012
- Head of Global Biology Quality & Biosafety since March 2006 (15 industrial plants)- Senior Director
- European Biology Quality Assurance Director (7 industrial plants)- March 2002 to march 2006.
- Quality Assurance Associated Director of Lyon sites - GLP (05/95-09/00) and GMP (05/95-03/02).
- Since 2000 – Member of the Quality Core Team of Merial Worldwide.
- Deputy Qualified Person for Merial SAS; for Head Office, LPA & Villeurbanne sites since March 2006.
- Deputy Qualified Person since May 1995 (Lyon Gerland Site).
- Merial was formed when Merck & Co. Inc. and Rhône-Poulenc S.A. (now sanofi-aventis) combined their animal health and poultry genetics businesses. Merial is a fully integrated, stand-alone company. 2007 annual sales exceed $2.4 billions.
- Set-up of Quality Assurance Organization and development of quality policy in order to:
--> Give Global Quality Support and Guidance to Merial Site Quality Operations (SQO) of the Bio Industrial Operations;
--> Develop expertise and networking in Quality to ensure that our Biological Industrial Operations are working in compliance with GMPs regulations and envision the required evolution to assure Merial leadership in such matter;
--> Guarantee the quality of our products and services as well as ensuring that the products meet specifications and legal demands, in addition to the needs of internal and external customers;
--> Maintain conformity to regulations for production units;
--> Manage our activities, through process, insuring improvement in the performing of our activities;
--> Set up the necessary conditions to unite the personnel around quality objectives;
--> Insure decision-making based on data, information and objective facts;
--> Develop efficient partnerships with our suppliers.
Fields of activity
- Quality Assurance:
--> Development of Quality Assurance policy for MERIAL’s European and International sites in accordance with GMP, GCP and GLP regulations (documentation, training, qualification, validation, audit);
--> Management of modifications and deviations, batch files implementation;
--> Quality management for the new building (DQ, IQ, OQ, PQ), setting up validation master plan;
--> Control of purchasing with regard to new regulatory constraints (EDQM, Pharmacopoeia…), guarantee of supplies (development of documentary support, external audit, internal flow…);
--> Validation policy of automated and computer systems (industrial equipment, GPAO, LIMS…);
--> Manage the global Product Quality Complaints (PQC) system;
--> Manage the global LIMS system;
--> Manage the global compliance system to Biosafety rules.
- Legal representative pharmaceuticals:
--> Taking over the legal responsibility in the absence of the qualified person;
--> Management of site approvals and site modifications for pharmaceutical establishments;
--> Management of official inspections (European & international);
--> Release of products.
- 30/15 people in the QA direction.
- External relations:
--> Chairman of the “establishment inspection” group within the SIMV “Syndicat de l’Industrie du Médicament Vétérinaire” (Veterinary Drug Industry Association);
--> Representing MERIAL for the CEESA “Centre Européen d’Etude pour la santé animale” (The European study center for animal health).
- European biology quality Assurance Director
2002 - 2006
- Quality Assurance Associated Director of Lyon sites
1995 - 2002
Laboratoire français du Fractionnement et des Biotechnologies
- Quality Department Manager
1992 - 1995
L.F.B. « Laboratoire français du Fractionnement et des Biotechnologies » (French laboratory for blood fractionate and biotechnology) – CRTS « Centre Régional de transfusion sanguine » (Regional blood transfusion center), Montpellier, France - Plasmatic medicine division.
Pharmaceutical Laboratory (Human medicine). Sector: Injectable medicines.
Company: production of medicines derived from plasma (Albumin, factor VIII….)
- Head of establishment (March 1995 – May 1995).
- Deputy Pharmacist (L.F.B., Montpellier establishment) (June 1994 – May 1995).
- Associate Director (October 1993 – May 1995).
- Quality Department Manager (Quality Assurance, Quality Control, Registration) until August 1992.
Fields of activity – Achievements
Management: 45 staff, 3 of which were executives; implementation of department follow-up; staff mobilization in view of obtaining pharmaceutical products and marketing authorizations.
Registration – Legal Pharmaceutical responsibility: Preparation and registration of pharmaceutical dossiers (LNS and Medicine Evaluation Agency); submission of six applications for marketing authorizations; design and validation of viral inactivation and/or elimination during production processes; application for the approval of a pharmaceutical establishment.
Quality Assurance (QA): Audit of the Quality Assurance system resulting in the improvement of communications between the different departments; design; setting up and managing of QA procedures and documentation manual; restructuring of QA documentation; verification and updating of specifications in accordance with pharmaceutical dossiers; training staff to GMP and ISO requirements; management of complaints; setting up of qualification/validation (equipment, production processes, transfer of licensed production processes); drawing up specifications with subcontractors and suppliers; management of inspections by health authorities.
Quality Control (QC): Release of finished products with evaluation of batch records; setting up and follow-up of validations and stability studies (as part of applications for marketing authorizations).
- Quality Assurance Manager
1988 - 1992
1988-1992: MXM, Sophia Antipolis, France.
Pharmaceutical laboratory (human medicine). Biomedical sector.
Sterilization (industrial unit for sterilization with ethylene oxide); production of physico-chemical integrators and biological indicators; pharmaceutical packaging (controlled atmosphere rooms, blisters); production of ocular implants; neurostimulation (signal processing, bionic ear, electrodes, European project).
- Interim Qualified Person (July 1990 – July 1992).
- Sophia-Antipolis production plant manager (human resources, production, logistics, etc.) (June 1989 – July 1992).
- Quality Assurance Manager (November 1990 – July 1992).
- Quality Control Manager (October 1988 – November 1990).
Fields of activity and achievements:
Legal Pharmaceutical responsibility: Follow-up of regulatory affairs as Interim Qualified Person for the company and Qualified Person for the production site; management of dossier of application for the authorization for pharmaceutical products for the new unit; management of dossiers for the extension of approval to new activities.
Quality Assurance (QA): Organization and follow-up of the different production flows in the new production unit; drafting and setting up management of QA and regulatory documentation; design and implementation of a staff training program; validation (production and sterilization processes); follow-up of production batches; management of health authority inspections.
Production: Interventions; responsibility for certain production processes; scheduling; human resources management; follow-up of batches and pharmaceutical dossiers (sterilization: BARD, FISONS, ALLERGAN, France – Italy – Ireland; L'OREAL; production: MSD, BECTON-DICKINSON, ALLERGAN OPTICAL, BIOMERIEUX).
Quality Control (QC): Launching and validation of a new assay technique on GPC; quality control of raw materials, production processes, and finished products; determination of analytical methods and tests to be performed; microbiological and physico-chemical tests; follow-up of various studies for NF authorization for a disinfectant.