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Zoetis
- Senior ESQA Manager
2015 - maintenant
o contractor management, new product introduction, product transfers, regulatory, contract process, contractor assessments/regulatory inspections and interactions , Business review meetings, audits, due diligence audits, development and implementation of ESQA guidelines and policies, mentoring, acting as back up of the department Director.
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Takeda
- Site Quality Head
Puteaux
2014 - 2015
o Position of Higher Management, with direct reports to Plant Director and Head of Global Operation Quality of Takeda Global. Member of the Direction committee. Quality responsibilities for manufacturing, packaging, Quality Control laboratories, development, project management, supply chain, regulatory inspections, supplier qualification, Qualification/validation, cleaning validation, VMP, Engineering and maintenance, GDP, RA and QP activities. Lead auditor for Takeda Global, main contact for Inspections and audits. Quality Council (global level). Main achievement: Implementation of GMP new chapters 3 & 5, new appendix 15, full site revamping according to new regulations and high potent manufacturing
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Solvay Peptisyntha
- QA Manager
2011 - 2014
o Quality Responsible for manufacturing, Quality Control Laboratories (microbiology included), packaging, supply chain, Engineering & Maintenance, development, QA on the floor, Customer Quality contact, Quality Affairs Manager (Quality Director) back-up, QMS improvement, training responsible, quality audit, customers audits, supplier audits, inspection management (EMA, ANVISA, FDA…), batch release, API release, documentation system owner. Main achievement: Full reconstruction of the Quality System, leading to FDA inspections without 483.
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GSK Biologicals
- Manager QA Support
Marly-le-Roi
2010 - 2011
o Provide QA support to operational QA for the internal compliance and continuous improvement. Improve the continuous Quality and the Compliance level.
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UCB Pharma
- QA Associate Quality Systems
COLOMBES
2008 - 2010
Responsible for the management of the internal audit system: ensure annual planning according to internal procedure, follow-up of audit execution and reporting, and KPI reporting to management.
Responsible for the management of the external audits planned on the site: organize and/or participate to preparation with impacted departments, ensure definition of CAPA plans as required and KPI reporting to management.
Responsible for yearly review of the quality management system: analysis of quality data, prepare management review and propose quality improvement actions.
Key business user for TrackWise® system, the central tool within the Quality Improvement Program (QIP): ensure training and advice to users of the software system, participate in improvement projects, maintain good practices on QIP related documentation.
Ensure review and implementation of Corporate procedures on local level.
Maintain and continuously improve the Quality Management System by defining and/or participating to quality improvement projects (project based implementation).
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Nextpharma
- Field QA Manager
2005 - 2008
o From March 2007 to August 2008, promoted to Field QA Manager (Department Manager, team and scope enlarged) Quality responsible for manufacturing (sterile area included), laboratories (included microbiology), packaging, development departments, Customer Quality contacts, Quality Director back-up, CAPA, QMS improvement, training, part of audit team Inspections (EMA, ANVISA…).Main achievement: Presence of QA on the filed lead to an increased level of confidence with customers (Including Japan), Authorities and between internal departments.
o From August 2005 to March 2007, QA in-process Manager. Quality responsible for manufacturing (sterile area included), laboratory, packaging, development department, Customer quality contact, part of audit team Inspections (EMA, ANVISA…). Main achievement: Successful implementation of QA department on the field leading to an increased level of confidence with customers, Authorities and internal departments.
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Laboratoires Thissen sa (NextPharma )
- QC responsible
1999 - 2005
