SANOFI

Qualité Sécurité Environnement

La vocation de Sanofi est d?accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d?une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l?innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l?inclusion sont au c?ur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d?inclusion et créer un environnement de travail où ces différences peuvent s?épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d?égalité des chances pour tous.

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. ABOUT THE JOB Our Team Within EM API entity, specialized in the management for Sanofi of APIs supplied externally, EM API CDMO team is in charge of new products launched from CDMOs partners. It implies that the team is the focal point for the CDMOs project managers and in Sanofi in close relationship with at least following stakeholders: Drug substance representatives in the CMC project team, Industrial Product team, Technical Chemistry Expert who assist and oversee the technical aspects of the drug substance manufacturing, Procurement, legal representatives. Mission Assist EM API CDMO Manager in the quality operational follow-up of CDMOs (Contract Development Management Organizations) involved in production, analysis & distribution of new chemical entities in launch phaseTake the responsibility for quality activities linked to these new flows of APIs ​ Main responsibilities Setup quality actions for integration of new flows (Agreement, Quality Agreements/Product Technical Sheets)In launch phaseParticipate and approve quality documentation relative to API launch activities (Process Design, PPQ Protocols & Reports, CPV, process and analytical transfers, stability studies API)Contribute to CDMOs Pre-Approval Inspection readiness (PAI Task Force participation)Ensure that scheduled activities are followed in a timely mannerAchieve key documents reviewEnsure integrity and traceability of data and documentation of the sitesAlert PTFL (PAI Task Force Leader) and PMG (PAI Management Group) about the hots topics which can arise in inspectionPrepare adequate position papers on main regulatory and technical hot topics, while interacting with project teamSupport sites to prepare ITAs, Mock-PAIs audits and follow-upSupport the resolution of identified gaps during this audit and CAPA plan follow-upParticipate to the PAI (back room), if requested by the site Assess on quality standpoint change controls and deviations/OOS of CDMOs,For major changes, support the CMC regulatory strategy in collaboration with GRA representatives and participation to Change Control CommitteeRegister in Phenix tool deviations and majors changes made by CDMOsFollow customer complaints in lien with API flowsReview batches abstracts relative to CDMO production campaigns, perform quality checklists to authorize shipment of concerned API batches (CDMO release oversight)In commercial phaseEnsure quality oversight of CDMOs: check audits achievements at appropriate frequency, update Quality Agreements, review main quality events and change, review Annual Product Quality documentation (PQR)Participate and approve new process or analytical validation strategy in the context of scale-up, LCM optimizationFollow quality KPIs & ScoreCard of CDMOsFollow action plans after audits, inspections, complaints etc of concerned CDMOsFollow registrations and regulatory watch: compliance with internal Sanofi guidelines and applicable regulations (Continuous Process Validation for new APIs) Contribute to animate EM API quality system and participate to all transversal quality meetingsParticipate to the SOP writing linked with CDMO management activities ABOUT YOU Education/experience: graduates with 5 years of higher education (Engineer, Chemist, Pharmacist) with experience of 3 years minimum in Quality. Experience in chemical development and/or Subcontracting is a mustSoft skills: Autonomy, Adaptability, Rigour, Commitment, Leadership, Ability to team and networking, Transversal cooperationTechnical skills: BPF (ICH Q7) – GMP & GDP API, Skills in chemical or analytical areaTools: PHENIX modules CC, QTP, QRM et E&CAPA, GEODE +Languages: English written, read and spoken required, fluent is a must, Italian, Chinese welcomed as well