Experience

LinKinVax

• France
• Biotechnology Research
• 1 - 100 Employee

• Head Of Quality

  • Mar 2022 - Present

  Provide QA oversight, technical QA expertise, support and leadership across the development of Vaccines the Pre-Clinical &Clinical Operations, GMP manufacturing batches, regulatory submissions Implementation of Quality Management System ( GXP) Implementation of electronic document and record management systems ( Veeva ( Software for life science document and process management); Validation ( IQ, OQ, PQ) Selection, Management and Evaluation of subcontractors ( CRO, CMO, testing laboratories, consultancy companies, etc.) Show less



Voisin Consulting Life Sciences (VCLS)

• France
• Biotechnology Research
• 100 - 200 Employee

• Global Quality and CSR Director

  • Aug 2018 - Mar 2022

  Member of the leadership team : - Management of all aspects of Global quality management system, Processes and Organization at VCLS worldwide - Management and development the CSR function, both strategically and operationally - Due diligence and risk advisory for acquisition ( VCLS acquisitions and private funds group) - Audit (ISO & GXP) - Mentoring SMEs - Conduct of organizational changes (quality, support services, load plan, Process Map, KPIs etc.) - Risk Management, management by processes - Implementing of QMS (GCP,GVP, ISO 9001:2015) - Contact with Regulatory Authorities (responsible for the preparation and coordination and management for the success of regulatory inspections GXP) Show less



GenoSafe

• France
• Biotechnology Research
• 1 - 100 Employee

• Head of Quality Department

  • Aug 2015 - Aug 2018

  Member of executive director team. Team Management : (Management by objectives) 1 MSc in regulatory affairs, 2 Bsc in molecular biology , 1 assistant GenoSafe is a full contract research and consulting organization specialized in the evaluation of cellular and gene therapy products. GenoSafe is GXP compliant , inspected by the ANSM the French authority. - Providing direction and leadership to Quality Assurance team and providing site leadership and commercial direction -Managing change, transformational culture - Management of supply chain - Implementing, maintaining and improving quality system (GMP, GCP, GLP), achieving quality assurance operational objectives by contributing information and analysis to strategic plans and reviews ; - Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business. - Promoting quality achievement and performance improvement throughout the organization; - Implementing electronic document and record management systems ( ENNOV ( Software for document and process management); - Preparing and completing action plans; implementing quality, and customer-service standards; - Identifying and resolving problems; completing audits; determining system improvements; - Managing HR training -Implementing and maintaining validation and qualification of equipment (QI, QO, QP) -Implementing and maintaining Health safety and environment management system Show less



E>Swin

• France
• Wellness and Fitness Services
• 1 - 100 Employee

• Senior consultant (Quality & Regulatory)

  • Mar 2015 - Jul 2015

  E-Swin (Manufacturing Medical Devices class IIb) Audit, Change Management Consultancy for ISO 13485, 21 CFR part 820 certification and regulatory strategy for the US Market E-Swin (Manufacturing Medical Devices class IIb) Audit, Change Management Consultancy for ISO 13485, 21 CFR part 820 certification and regulatory strategy for the US Market



Auriga Partners

• France
• Investment Management
• 1 - 100 Employee

• Senior consultant

  • Oct 2013 - Mar 2015

  Consultancy for a private equity specialized in investment in biotechnology companies Research study: Management of innovation in SMEs, ESG Risk ratings Auriga partners, 2 degrees investing initiative, Kids'M Consultancy for a private equity specialized in investment in biotechnology companies Research study: Management of innovation in SMEs, ESG Risk ratings Auriga partners, 2 degrees investing initiative, Kids'M


DestinationSanté.com
• France
• Information Services
• Animatrice radio

  • Apr 2007 - Jan 2015


TcLand Expression

• France
• Pharmaceutical Manufacturing

• Quality Director

  • Jan 2008 - Jul 2013

  Member of executive director team Participation in fundraising Ensuring ISO 17025 Accreditation and compliance with iso 13485,Iso 14971, 21CFR Part 820, 510 (K) Method Validation Manager Promoting quality achievement and performance improvement throughout the organisation Member of executive director team Participation in fundraising Ensuring ISO 17025 Accreditation and compliance with iso 13485,Iso 14971, 21CFR Part 820, 510 (K) Method Validation Manager Promoting quality achievement and performance improvement throughout the organisation



Eurofins Lancaster Laboratories Professional Scientific Services, LLC

• Quality Assurance Manager

  • 2006 - 2007

  Ensuring compliance with ISO 17025 v 2005 Method validation Manager for forensic analysis Ensuring compliance with ISO 17025 v 2005 Method validation Manager for forensic analysis



Saint Antoine Hospital (Paris)

• Clinical Auditor

  • 2005 - 2006

  Auditing clinical studies ( ICH GCP requirements) Auditing clinical studies ( ICH GCP requirements)



Vivalis (CMO)

• Quality Assurance Officer

  • 2005 - 2006

  Ensuring compliance with cGMP Ensuring compliance with cGMP



Biotrial (CRO)

• Quality Assurance Officer

  • 2004 - 2004

  Ensuring compliance with cGCP and cGLP Ensuring compliance with cGCP and cGLP



Clean Cells

• France
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Officer

  • 2003 - 2003

  Implementing Quality system for the research department Clean cells is a company specialized in biosafety testing Implementing Quality system for the research department Clean cells is a company specialized in biosafety testing



Genoscope and Genethon

• laboratory assistant

  • 2002 - 2002

  Performing specific analyses using Molecular biology and cell biology techniques/Performing recombinant DNA library construction; screening, isolation and mapping clones; oligonucleotide hybridization; plasmid subcloning, and/or screening DNA libraries Performing specific analyses using Molecular biology and cell biology techniques/Performing recombinant DNA library construction; screening, isolation and mapping clones; oligonucleotide hybridization; plasmid subcloning, and/or screening DNA libraries