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Summary

r&d Quality Assurance professional, Clinical trials Auditor, root cause mapping specialist and risk-based thinker, always interested by qa Leadership and/or Auditing opportunities in europe or north america.

• expertise in Clinical trials qa and Auditing ; capa implementation and follow-up, rca, sops development (ich-gcp, FDA & EMA regulations, including 21 CFR Part 11)

• expertise in Lab quality (gclp, ISO 15189, glp)

• experienced Auditor, detail orentied, with great Problem Solving skills, excellent written and verbal Communication Skills and able to communicate effectively at all levels to influence and make recommendations fr improvement.

• Project Management of r&d projects in a context of Clinical trials and Preclinical studies

• knowledge in related fields to improve quality and safety : rca, root-cause mapping, 6 sigma, Risk Management, behavior-based safety, Research Ethics evaluation

• more than 10 years of experience in Life Sciences Research, 7 years of experience in Quality Assurance

• experience in working with people from different cultures and backgrounds, strong capability of adaptation to new environments

Experiences

Current Experience

  • Consultant, Project Manager

    Palaiseau, France
    Since July 2017

    Project Manager of international Research and development projects sponsored by danone Research: Preclinical studies and Clinical trials conducted under EMA regulations.

    set-up and management of projects in the field of Metabolism and Gastroenterology (mainly to assess healthy benefits of probiotics), and method development / analytical projects. 

    management of projects from 30 ke to 400 ke.

     

     

    Project Manager of international Research and Development projects sponsored by Danone Research: preclinical studies and clinical trials conducted under EMA regulations.

    Set-up and management of projects in the field of metabolism and gastroenterology (mainly to assess healthy benefits of probiotics), and method development / analytical projects. 

    Management of projects from 30 kE to 400 kE.

     

     

Past Experience

  • Clinical QA Consultant Paris, France

    March 2017 --- June 2017

     aixial is a French-based CRO involved in international Clinical trials mainly in europe

    gcp Auditor

  • QA Manager Burkina Faso

    July 2011 --- January 2017

    qa managerset up, development and management of the qa department, responsible for ensuring Compliance of the Quality System with the international standards, in the context of malaria vaccine and drugs Clinical trials and ebola vaccine trials.

    redaction of the institution quality Policy and the laboratories quality manual and biosafety manual. coordination of the development and review of sops to ensure gcp Compliance at Clinical research sites. set up of the Quality Management System for the laboratories. regular Clinical research sites inspections. providing regulatory and GXP Compliance advice and support for Clinical trials investigators to improve the quality of the activities.

    lead Auditor: internal audits based on the risk to identify areas of quality and Compliance vulnerability during the conduct of Clinical trials and research activities. audit report. preparation of capa plan, support of capa implementation, management and effectiveness follow-up. second party audits (referral laboratories, suppliers).

    Trainer: Coordinator and main Trainer of internal qa and GXP Training program

    key achievements: dramatic reduction of non-conformities during internal audits; improvement of the workflow on Clinical research sites; improvement of the safety and well-being of Clinical trials subjects; strong improvement of the Lab’s qms with a selection by edctp as one of the 3 best institutions in west africa for the development of the clinical laboratories qms. the cnrfp was also recognized in 2015 as a centre of excellence in malaria drugs and Vaccines development by the african network for drugs and Diagnostics Innovation (andi).

  • Scientific consultant

    December 2009 --- April 2011

    Pharmacists without borders - ivory coast is a little structure involved in the development of health systems and the quality of Health Care.

    project for the st michel health center (located in the central west of the country). the center was specialized to support buruli ulcer patients; design and start of a Research project on buruli ulcer, abandoned because of the ivorian crisis (late 2010/early 2011).

    set up of qa and biosafety program in the health center including the Medical laboratory (development of sops, implementation of internal qc, improvement of Sampling quality, etc.) hiv/aids and malaria prevention & improvement of sanitation in urban areas (abidjan).

  • PhD student

    September 2006 --- October 2009

    gicc is a Research unit of the cnrs - Genomics, Immunology, Chemistry and Cancer

    phd: study of the DNA dynamics with transposable elements to design a non-viral vector for Gene transfer. Discovery of inhibitors of eukaryotic transposases, some working on hiv-1 integrase. 4 scientific articles in peer-review journals, participation to 4 national and international conferences. Lecturer at bsc and MSc level in Genetics.

Personality

Self Assessment :
AdaptabilityAttention to detailCommunicativeCreative thinkingOptimismOrganizationProactivityProblem solvingResult OrientedSelf-disciplineAnalytical thinkingFlexibility

Knowledge

Self Assessment :
GXPAuditingQuality ManagementGCPGood Scientific PracticesGCLPSOP development21 CFR Part 11TrainingCAPARoot Cause Analysis (RCA)Cause mappingISO 15189ISO 9001Risk-based ThinkingSix Sigma R&DBiosafetyBehavior-Based Safety
LinkedIn Assessment :
CWA 15793Behavior-Based SafetyRisk ManagementQuality ManualSOP developmentResearchPublic SpeakingEnglishClinical researchQuality SystemICH guidelinesClinical trialsBiosecurityISO 9001BioethicsMolecular geneticsInfectious diseasesPhotographyCreative WritingSports CoachingSports WritingRecherche cliniqueQuality AssuranceGCPGCLPISO 15189GLPBiosafetyQuality ControlAuditingTrainingInternal AuditRisk-based ThinkingBiorisk ManagementRegulated Research

Skills and Expertise

Self Assessment :
Develop ICH/GCP compliant processesEnsure good clinical practice (GCP)Implement and Maintain Quality Management SystemPerforming Root Cause AnalysisAssess site feasabilityProvide staff trainingImplement and monitor KPISOP developmentConduct GxP and ISO AuditsConduct research auditsRisk-based audit planification

Education

  • PhD in Molecular Genetics & Genomics from Université François Rabelais de Tours in 2009
  • Master in Infectious disease & Vaccinology from Université François Rabelais de Tours in 2006

Training and Certification

  • Root Cause Analysis in 2017 Certification
  • Good Clinical Practices in 2016 Certification
  • Business Risk Management in 2015 Certification
  • Decoding ISO 15189 in 2015 Certification
  • ISO 9001 QMS Auditor / Lead Auditor in 2015 Certification
  • Six Sigma Yellow Belt in 2015 Certification
  • How to conduct GCP inspections/audits in 2014 Certification
  • Basic QC Practices in 2012 Certification
  • Good Clinical Practice in 2012 Certification
  • Protecting Human Research Participants in 2012 Certification
  • Secrets of Method Validation in 2012 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    QA Consultant QA Lead QC/QA Manager Quality manager GxP Auditor
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
  • International:
    Yes

Publications

    Expert has 6 publications (Will be avalible with full profile)

Area / Region

Île-de-France, France

Others

Driving License
  • Yes

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