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JOHNSON & JOHNSON
- Quality and Compliance Director
New Brunswick
2013 - 2018
CAREER HISTORY WITHIN JOHNSON & JOHNSON: .
(Marketing Companies)
DePuy Synthes
- Support Legacy Synthes affiliates integration to JnJ Marketing Companies worldwide
- Harmonization of QA systems for training, documents, CAPA and Complaint reporting
- Transfer of knowledge for Synthes specific processes and products
- Agent of liaison between the Franchise and the Local Operating Comapnies
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Johnson & Johnson
- FPX Program Director, Global Remediation Quality
New Brunswick
2012 - 2013
DePuy Synthes
- Development of the Global Quality Remediation Plan (GRQP) with the Depuy Synthes team in response to FDA
483s and Warning Letter.
- Assure that the GRQP program is established as per FPX methodology and progresses in accordance with the schedule
- Develop and deploy standardized processes, tools and metrics to implement GRQP in a consistent and effective manner across the 27 legacy Synthes locations around the world
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Johnson & Johnson
- Director Quality Operations - Strategy & Project Management
New Brunswick
2011 - 2011
Medical Devices and Diagnostics - Global Supply Chain
- Development and Implementation of short and long term Strategic Plan for the Global Quality Operations
Program across the MD&D business sector of Johnson and Johnson.
- Project leadership role in several critical initiatives to drive standardization and reduce compliance risk across the sector such as: Do It Right, Packaging Risk Reduction, Q&C Core Competency Model, MD&D Supplier Quality
Standards.
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International Projects (Johnson & Johnson)
- Quality Director
2011 - 2013
* Evaluation et mise en conformité des sociétés acquises par le groupe
* Gestion de Projets Internationaux
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Johnson & Johnson Medical (Suzhou) Ltd
- Director Quality Systems and Regulatory Affairs
2006 - 2011
Developped a fully integrated Quality Management System for a new site in China manufacturing Medical Devices (Class
I, II and III) for WW distribution. Starting from a green field, the production expanded as per schedule, and the site is ISO-
13485 certified and successfully audited by US FDA. (300 employees - 100 Mi USD investment)
Quality:
- Management Site representative
- Designed and implemented a flexible QMS framework to facilitate the integration of other franchises under a Campus shared model
- Executed a very aggressive product transfer plan and production ramp-up while maintaining a flawless compliance profile
- Obtained ISO-13485 certification, Chinese SFDA Manufacturing license and RDC-59 ANVISA certification
- Successfully passed US FDA inspection with zero 483's
Regulatory Affairs:
- Developed a program and tools to accelerate the registration of China manufactured products
- Worked actively with local, regional and State SFDA (China) to shape external environment
- Clarified and communicated the complex domestic registration requirements in China to assist overseas partners in their strategic business decisions.
Leadership and people development:
- Recruited/Managed culturally diverse staff
- Designed and executed successful strategies to develop/retain critical talents in a challenging environment
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DePuy Ireland Ltd
- Quality Engineering Projects Manager
2004 - 2006
Product transfers between USA and Europe
- Leadership role in worldwide projects (7 sites - 4 Op Co)
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DePuy Inc.
- Validation manager
2003 - 2004
Developed, and executed the validation plan including Product shelf life, disinfection process for orthopaedic implants using animal tissues
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DePuy France
- Validation Manager
2001 - 2002
In charge of Microbiology, Quality Engineering, Packaging and CSV/ 21 CFR Part 11
- Validation and implementation of a plasma HA coating process.
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DePuy France
- Quality Engineer
1999 - 2000
Adaptation of the existing Quality System to fulfil J&J and FDA requirements
- Validations (IQ/OQ/PQ) of clean-room, clean-line, packaging and sterilization processes
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JOHNSON & JOHNSON
- Quality Manager
New Brunswick
1995 - 1999
Supervision of 4 sites
- Obtension of EAQF and ISO 9002 certifications
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Plasto Adhesifs
- Quality Supervisor
1993 - 1994
In charge of the physical properties laboratory and the receiving inspection
- Implementation of statistical sampling methods to ensure the incoming inspection of 10,000 deliveries per year
- Test method validations and development of a database to monitor, trend and analyse lab results.
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Relais Electronic Deutsh
- Quality Assurance Engineer
1991 - 1992
Relais Electronic Deutsch - Telecom & Aerospace Industries - France
- Quality Engineering for new product developments
- Member of the U.T.E (Electrical Technical Union), responsible for the national and international standard.
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Sofradir
- Quality Engineer
Veurey Voroize
1987 - 1990
Start-up of a micro-electronic company (Infra-red detectors)
- Transfer of technology to a German Company
