Françoise VEYRIAC

Quality Assurance Regulatory Affairs Manager & Clinical Affairs Manager at Tribun Health, AI-powered Pathology
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Contact Information
us****@****om
(386) 825-5501
Location
Versailles, Île-de-France, France, FR
Languages
  • Anglais Full professional proficiency

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Juliette Moulin

J’ai travaillé avec Françoise à l’occasion de plusieurs missions. Françoise était l’un de nos prestataires. La mission la plus importante aura été la mise en place puis l’opération Ali dation de l’ATU Daklinza. Cette ATU était très stratégique pour l’entité pour laquelle je travaillais. A cette occasion Françoise aura démontré sa capacité d’écoute, ses qualités relationnelles auprès d’interlocuteurs différents tant par le métier que par la nationalité voir la personnalité. Françoise écoute, propose, et est force de propositions. Elle a démontré un sang froid et une gestion opérationnelle admirable. Cette mise en place d’une ATU stratégique avec de multiples interlocuteurs, client, hôpitaux, ANSM montre la capacité d’adaptation de Françoise tout en préservant l’organisation de sa propre structure et la rentabilité du projet pour sa propre entreprise. Je recommande donc Françoise pour ses qualités opérationnelles, sa capacité à gérer des projets complexes, sa capacité d’adaptation, sa position managériale et enfin son adaptabilité à travailler avec des organisations pluridisciplinaires.

Christiane Guinot

Les qualités de Madame Jouve que j'apprécie personnellement sont, outre ses compétences professionnelles, sa pensée critique, son écoute, sa ténacité et sa motivation, et son très bon contact avec les personnes des différentes équipes impliquées dans tous les projets dans lesquels elle est engagée. Elle excelle dans la planification de projets et dans la direction d'équipes. Elle est également douée d'un excellent sens de la communication.

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Experience

    • France
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Regulatory Affairs Manager & Clinical Affairs Manager
      • Feb 2022 - Present

    • France
    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • Chief Operating Officer & QARA Manager
      • Nov 2020 - Jun 2022

      Board member, 12 FTE - Lead and implement the strategic products portfolio development (medical devices & medical software) meeting both up-to-date regulatory requirements (EU, FDA) & constraints of digital health field (IA, ENS, ...), while supporting innovations through strong market analysis. - Create, roll out and manage a QMS to maintain and guarantee compliance with regulatory requirements. Successful implementation of mandatory standards applicable to software as medical device as EU MDD & MDR, 21 CFR part 820, ISO 13485, ISO 14971, MEDDEV. - Advocate strong quality culture by providing training and ongoing support to staff in the use of the QMS to ensure compliance medical devices deployment. - Direct, oversee technical dossiers & associated documents constitution to obtain Medical Device CE conformity marking. - Define and lead a strategic clinical research program to optimize medical devices development and gaining FDA & EU certification approvals: lead Clinical Trials & supervise FDA pre-submission. - Create, develop and implement materiovigilance processes (complaints, vigilance cases, nonconformities). - Serve as a key member to decide and develop overall business strategy. Show less

    • France
    • Hospitals and Health Care
    • 700 & Above Employee
    • Transition Manager
      • Feb 2020 - Nov 2020

      - Support changes by dealing with financials & time sensitive tasks. - Establishment management in its dual social and economic dimension. - Ensure optimal quality of medical care and accommodation, especially in times of crisis: Covid, lack of personnel. - Develop and foster positive long-term relationships with local actors (ARS, CCAS, health care institutions, ...) to ensure the growth of the establishment. - Support changes by dealing with financials & time sensitive tasks. - Establishment management in its dual social and economic dimension. - Ensure optimal quality of medical care and accommodation, especially in times of crisis: Covid, lack of personnel. - Develop and foster positive long-term relationships with local actors (ARS, CCAS, health care institutions, ...) to ensure the growth of the establishment.

    • France
    • Hospitals and Health Care
    • 700 & Above Employee
    • Transition Manager
      • Dec 2018 - Feb 2020

      - Operating teams reorganization (catering, accomodation, medical care) to improve efficiency. - Ensure optimal quality of medical care and accommodation, specially during crisis (sttaff shortages, heat waves). - Support changes by dealing with financials and time sensitive tasks. - Develop and foster positive long-term relationships with the French health authority to ensure establishment growing. - Steering establishment renovation (renovation on an occupied site). - Operating teams reorganization (catering, accomodation, medical care) to improve efficiency. - Ensure optimal quality of medical care and accommodation, specially during crisis (sttaff shortages, heat waves). - Support changes by dealing with financials and time sensitive tasks. - Develop and foster positive long-term relationships with the French health authority to ensure establishment growing. - Steering establishment renovation (renovation on an occupied site).

    • France
    • Information Technology & Services
    • 200 - 300 Employee
    • Head of Operations
      • Nov 1992 - Apr 2017

      Co-founder of the company; Board Member - Direct line manager (13 people), 140 FTE, 3 sites - Design and embed global business strategy and tactics to ensure company growth (relevant proposals, flexible service offer as particularly IN & OUTSOURCING, partnership development). - Develop and drive annual budget.- Manage the PxL through relevant data analysis. - Lead human resources (recruit, coach, develop, set objectives, assess performance, reward, address issues, ...) to ensure projects adequate staffing, reliability and expertise of services provided. - Lead business proposals and contract negotiations by providing strong expertise into clinical trials conduct and analysis in broad therapeutic areas, focusing on customers' expectations to gain profitable bew business contracts. - Boost company efficiency through constant operational processes improvements including programming, data management and biostatistics. - Build and manage a QMS and quality policy to ensure deliver compliant clinical studies (from design to reporting) with regulations, guidelines and requirements (GCP, EMEA, FDA, ICH, CDISC). - Advocate QMS adherence and processes and deliverables qualities, by implementing annual audit plan, relevant CAPAs, updating SOPs and training staff. - Provide expert operational oversight and guidance to prioritize, staffing, and activities execution (130 projects/year) to ensure clinical trial delivering, with quality, and budget compliance. Show less

    • Head of Global Operations
      • 2016 - 2017

      - Management of the merger with 2 CROs (30 people & 50 research projects): clinical and epidemiological research pole reorganization, pooling of processes and skills, service offers extension, support for teams in the change, optimization of professional efficiency- Manage service offering strategy adaptation in Eastern Europe

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Biostatistician
      • Sep 1990 - Oct 1992

      Data management and analysis of clincial study Data management and analysis of clincial study

    • France
    • Retail
    • 700 & Above Employee
    • Développeur applications
      • Mar 1988 - Sep 1990

      Développement en langage C ou fortran d'applications permettant aux chefs de rayon d'optimiser leurs activités opérationnelles : analyse des besoins, programmation, déploiement, formations et support aux utilisateurs Développement en langage C ou fortran d'applications permettant aux chefs de rayon d'optimiser leurs activités opérationnelles : analyse des besoins, programmation, déploiement, formations et support aux utilisateurs

Education

  • Institut Léonard de Vinci
    MBA D3S: Health Management, Administration / Management of care establishments
    2017 - 2018
  • CNAM
    Ingénieur en Informatique Scientifique (Master 1), Biostatistique
    1988 - 1991

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