Stéphanie Basinski
Paris
Summary
As a quality manager with more than 10-year background in developing and commercializing in vitro diagnostic (IVD) product, my role consists in implementing and improving quality systems to ensure compliance with industry standards and regulations. Proven track record of ensuring product quality, regulatory compliance, and operational efficiency in IVD settings.
Overview
18
18
years of professional experience
Work History
Senior Quality Manager
Mobidiag, A Hologic Company
07.2017 - Current
- Developed, implemented and maintained Quality Management Systems (QMS) compliant with ISO 13485 and/or ISO 9001. ISO 13485 certification renewed in 2023 by BSI.
- Ensured conformance and continuous improvement (NCE, CAPA, KPI, Management Review)
- Integrated local QMS into Hologic Corporate systems.
- Ensured product compliance to regulatory and quality requirements. Experience in obtaining CE-marking under IVDD (general IVD) and IVDR (class A).
- Liaised with French Competent Authority (ANSM).
- Coordinated and carried-out internal, external and supplier audits.
- Line management of 2 quality engineers.
Project Manager, New Product Development & Quality
Diaxonhit
01.2008 - 07.2017
Project Management:
- Managed new product development projects (1 drug candidate, 5 IVD products) to ensure timely delivery and compliance to regulatory and internal requirements.
- Owned Design Control process.
Quality Assurance:
- Implemented and managed Quality Management System compliant with ISO 13485 and ISO 9001. ISO 13485 and ISO 9001 certifications renewed by GMed in 2017.
- Liaised with French Competent Authority (ANSM).
- Coordinated and carried-out internal and external audits.
Project Planner
C.I.T.
03.2007 - 12.2007
- Optimized preclinical project schedules by allocating resources and closely monitoring progress.
Project Planner
Servier Pharmaceutical
02.2006 - 12.2006
- Optimized clinical project schedules (phase II and phase III) by closely monitoring progress.
Education
Internal Auditor Training
AFNOR
Lyon, France2019
Cross-functional Management
CEGOS
Paris, France2015
Project Management Methodologies And Tools
CEGOS
Paris, France2014
Master of Science - Project Management For Healthcare Industry
Université D'Auvergne
Clermont-Ferrand, France2006
Skills
- Regulatory compliance: Directive 98/79/EC, Regulation 2017/746, harmonized standards for medical devices (non-sterile products, assay - instrument - software)
- Advanced knowledge on ISO 9001, ISO 13485, ISO 14971, IEC 62366 and IEC 62304
- Quality Management and Continuous Improvement
- Design Control and Change Management
- Quality Auditing
- Project Management
- Electronic Document Management Software Systems: Agile, M-Files, Ennov
- CliftonStrenghts: Communication - Arranger - Developer - Positivity - Strategic
Languages
English
Advanced (C1)
Timeline
Senior Quality Manager
Mobidiag, A Hologic Company
07.2017 - Current
Project Manager, New Product Development & Quality
Diaxonhit
01.2008 - 07.2017
Project Planner
C.I.T.
03.2007 - 12.2007
Project Planner
Servier Pharmaceutical
02.2006 - 12.2006
Internal Auditor Training
AFNOR
Cross-functional Management
CEGOS
Project Management Methodologies And Tools
CEGOS
Master of Science - Project Management For Healthcare Industry
Université D'Auvergne
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