Imen chouchen

✅Diagnostic QMS et stratégie qualité sur mesure : - Evaluation complète de votre systéme qualité et recommendations sur la stratégie qualité alignées avec vos objectifs business ✅Mise en place ou optimisation de votre système de management de la qualité ✅Mise en conformité ISO9001 et/ou bonnes pratiques de distribution ✅Réalisation de vos audit qualité fournisseurs de distribution/Stockage/transport ✅Gestion de projet de digitalisation de votre QMS - transition vers un e-QMS ✅Accompagnement dans le développement d’une culture qualité durable - programme sur mesure

• Team management: 3 quality experts with direct hierarchical link • Responsible for supplier quality management governance: qualification, contracts, and performance monitoring • Responsible for the governance of non-conformities, CAPA, Customer complaint • Implementation of risk and opportunity management process • Development and monitoring of quality performance indicators • Strengthen the continuous improvement concept and actions as per PDCA • Project management: implementation and deployment of an e-QMS, implementation of a digital solution to manage quality alerts ➢ Key achievements: Leading the project of revamping and harmonization of customer complaints process / Improve the complaints handling of a key business customer / Full qualification of global critical suppliers from 0% to 75% as per a new global qualification process / Deployment and roll out of Intelex eQMS globally and across sites acting as project leader

Lead for Africa and Middle east countries (Affiliates and distribution partners), EU (FRANCE, UK, Spain /Portugal, Germany, Italy, Ukraine) => more than 25 distribution partner and 10 affiliates • Responsible for Ipsen affiliates or Alliance partners: GxP oversight in collaboration with the business through quality monitoring, mock audit and contract negotiations • Managing quality aspects during acquisitions, transfers, product launch, storage and distribution facilities launch, affiliate opening • Participate to RFP decisions during distribution partner selection • Ensure the local deployment & adherence to the global QMS (roadmap definition and follow-up) • Act as point of liaison between affiliates and global audit team: pre-assessment of the GxP activities and support the establishment of global audit program through a riskbased approach • Distribution partner management: quality due diligence, re-assessment, QTAs, annual evaluation • Customer complaint management & temperature excursions ➢ Key achievement: 100% of distribution partners have a QTA signed, establish regular communication channel within alliance partners – Lead the project launch of a new distribution and storage warehouse from facilities selection until readiness to obtain distribution license from local authorities with success – Support the launch of new affiliate in MEA and transfer from alliance partner presence to direct presence – Act as global quality representative to implement and deploy a new eQMS and ensure that the system is well implemented at local level

-Implementing an integrated quality system according to ISO9001 & ISO 13485 -Implementing the ISO9001 process approach and process cartography -Animation of a workshop with process owners to increase the adherence to ISO9001 ➢ Key achievement: Map of Macro processes as well as key operational process – Risk management tool creation – 50% of the integrated QMS completed

• Resolution of product quality compliance issues • Quality System Implementation & Management • Local product disposition (release of imported product) • Supporting Inspections (external & internal) • Quality oversight of managed third-party contractors, manufacturers, local packaging/labeling partners, analytical laboratories and distribution centers within the region • Ensuring Quality Agreements are in-place where necessary and their requirements are met. • Supporting the validation of warehouse and cold store, shipping solution qualification, product returns process, Good Distribution Practice (GDP) standards implementation • Development and maintenance of consistent quality culture • Conducting quality trainings ➢ Key achievement: Participation and support the readiness of the Pfizer distribution hub in Dakar

• Deviation &out of specification handling and management • Root cause analysis and problem solving of all product quality issues • Animate quality committees • Elaborate internal quality key performance indicator • Internal auditor • Elaborate risk assessments / Daily GMP's assessment in manufacturing sites • Annual product review « APQR »