Clinical Quality Assurance Specialist H/F Excelya
- Lyon - 69
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
AbouttheJob
JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.
Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovatio andmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.
Activities
- Review QA documentation related to clinical trials
- Ensure completeness of clinical and quality records
- Assess and track complaints from CROs and sites
- Review audit reports and monitor follow-ups
- Manage SCARs (Supplier Corrective Action Requests)
- Support CAPA implementation and closure
- Follow up on non-conformities (NCFOs)
- Oversee QA documentation for clinical development
- Support GCP inspection readiness (EMA, ANSM, FDA)
- Ensure compliance with GCP and internal SOPs
- Perform QA gap analyses and suggest remediations
- Follow up on audit findings and CAPAs
- Coordinate with internal stakeholders (ClinOps, RA, PV)
- Contribute to QA process improvements and mock inspections
WhyJoinUs?
AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.
Here'swhatmakesusunique:
Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.
Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- Experience:5 years of proven experience in Clinical QA in a sponsor environment, experience preparing for regulatory GCP inspections, familiar with audit processes and CAPA management
- Skills: Strong knowledge of GCP and clinical trial regulations, excellent organizational and documentation review skills, ability to work autonomously and proactively, strong communication and collaboration skills
- Education:Degree in Life Sciences or related field (BSc, MSc, PharmD, or equivalent)
- Languages:Fluent in French and English (written and spoken)
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
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Publiée le 22/09/2025 - Réf : 7d71e12b-164c-49c6-bbdd-90df2b4a06c7
Clinical Quality Assurance Specialist H/F
- Lyon - 69
- CDI
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