{"id":3864391,"url":"https://alion.io/job/lfb-responsable-assurance-qualite-systemes-informatises-data-integrity-hf","title":"Responsable Assurance Qualité Systèmes Informatisés / Data Integrity H/F","company":{"id":2345173,"name":"LFB","domain":"groupe-lfb.com","url":"https://alion.io/company/groupe-lfb","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":91,"open_postings":6,"ghost_share":0,"stale_share":0.167,"repost_share":0,"time_to_fill_p50_days":76,"computed_at":"2026-11-10T06:52:35Z"}},"role":"DevOps","role_family":"DevOps","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Arras, France"],"countries":["FR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-11-06T11:28:46Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-10T03:25:31Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"QUELLES MISSIONS VOUS SERONT CONFIEES ?\nSous la supervision de la Direction Qualité du site industriel d’Arras, vous êtes responsable pour le site de l'Assurance Qualité des Systèmes Informatisés et du programme Intégrité des Données (DI). A ce titre, vous managez une équipe de 3 personnes.\nDans ce cadre, vos missions se déclinent ainsi :\nPiloter la performance de son équipe dans l’excellence et les valeurs de l’entreprise \nRédiger à partir des procédures corporate groupe les procédures locales du site (revue et approbation)\nAnimer et piloter les comités de pilotage Data Integrity du site\nParticiper et approuver les Data Integrity Risk Assessment (DIRA) et le plan de remediation associé\nSuivre les CAPA de remédiation, communiquer les indicateurs et les réalisations au comité de direction et au Data integrity compliance officer groupe.\nRédiger le rapport Data integrity annuel du site\nPrésenter en audit et en inspection réglementaire les sujets DI du site\nParticiper au traitement des déviations relatives à des problèmes de DI\nParticiper aux réunions pluridisciplinaires sur les changements (DCI) de production et laboratoires pour veiller à la bonne intégration des aspects DI dans les URS et la validation\nProposer à la Direction les CAPEX liés à l’amélioration du niveau de compliance DI\nTravailler en collaboration avec l’informatique Industrielle et la DSI sur les aspects DI\nElaborer et contribuer à la mise en place le plan data integrity du site, en lien avec le plan global Qualité DI groupe, et avec les priorités définies dans le plan qualité du site\nAnimer la préparation des Inspections réglementaire pour tous les sujets relatifs à l'intégrité des données\nEtre le donneur d’ordre sur le budget DI du site\nQUEL PROFIL POUR CETTE OPPORTUNITE ?\nDe formation Bac + 5 dans domaine scientifique ou qualité, vous justifiez au minimum de 10 années d’expérience sur des activités de Data Integrity et de validation des Systèmes Informatisés dans l’industrie pharmaceutique.\nConnaissances des référentiels Qualité et réglementation en vigueur\nMaîtrise des processus et outils Qualité : amélioration continue, déviations/CAPA/Change control\nGout pour la gestion de projets et le management transversal\nAnglais courant \nQUELS AVANTAGES LIES A CE POSTE ?\nPoste à pourvoir en CDI\nAccord de télétravail : jusqu’à 2 jours par semaine, dès 4 mois d’ancienneté\nJours de RTT + 3 jours de congés supplémentaires\nParticipation aux frais de transports\nAvantages Groupe : mutuelle, prévoyance, CE, PEG/PERE-COavec abondement, Compte Epargne Temps","description_format":"text","description_chars":2550,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"French","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-06T11:28:46Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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