Herveline Fournier

Quality Assurance Lead Manager @Fortrea

Montpellier, FR
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2022 — Present

Quality Assurance Lead Manager @Fortrea

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Montpellier, FR

Assessment and Evaluation of Quality Issues in QMSProvides QA support and oversight of the investigation, root cause analysis and CAPAOversees timely completion of CAPAs and QIs in QMSHosting and supporting of Sponsor Audits and Regulatory Authorities Inspections Providing QA consultation and guidance to the Project teamManages the QA to QA relationship with assigned key clientsInteracts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notificationsProvides a monthly report of activities to Sr. QA Manager/QA portfolio Manager and in pulling metric data, trending and tracking of QIs and client metricsManages writing of Quality Agreements

EDUCATION

2002 — 2008

Université François Rabelais de Tours

Doctor of Pharmacy (Pharm.D.)

2014 — 2015

Université Paris Descartes

D.U Auditeur qualité dans l'industrie du médicament

2011 — 2012

Université Pierre et Marie Curie (Paris VI)

DIU CESAM (Méthodologie Statistique et Pratique des Essais Cliniques)

SKILLS

Audit ExterneAssurance QualitéCROPharmacovigilanceOncologyPharmaceutical IndustrySopRecherche CliniqueBonnes Pratiques CliniquesEssais CliniquesDocuments RèglementairesClinical TrialsAudit InterneSciences De La VieAffaires RéglementairesGestion De Projet InternationalClinical ResearchCapaAuditQuality AssuranceSecteur PharmaceutiqueAudit Qualité

ABOUT HERVELINE FOURNIER

Clinical QA leader experienced in portfolio‑level quality oversight and building…

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Herveline Fournier — Quality Assurance Lead Manager at Fortrea in Montpellier, FR | Unifers