Critères de l'offre
Métiers :
- Spécialiste Gestion Documentaire Qualité (H/F)
Expérience min :
- 21+ ans
Secteur :
- Santé
Lieux :
- Paris (75)
Conditions :
- CDI
- Salaire non précisé
- Temps Plein
L'entreprise : IPSEN
Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.
Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.
Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.
Description du poste
Shape the Future of Global Quality Systems at Ipsen
At Ipsen, we are committed to improving patients' lives through innovation, collaboration and excellence. As our next Global Quality Systems Manager, you will contribute to the compliance, harmonisation and continuous improvement of our Global Quality Management System.
The Role
Reporting to the Global Quality Systems Director, you will provide operational expertise in Global Quality Systems, with a primary focus on GxP document management and training management. You will lead defined activities within these areas and support the relevant Global Business Process Owners.
What You'll Be Doing
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Act as a Subject Matter Expert for Global GxP document management and as Document Manager for the Global Quality entity in the electronic Document Management System, supporting controlled document lifecycle activities.
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Manage key Global Quality documentation activities, including the periodic review of GxP procedural documents and the monthly communication of Global cross-functional GxP documents.
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Act as LMS Administrator and Training Specialist for Global Quality, maintaining training matrices, Learning Objects, curricula and user profiles.
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Monitor Global Quality GxP training compliance and support the harmonization of documentation and training practices across functions, entities and sites.
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Lead or contribute to Quality Systems improvement initiatives and support the integration of newly acquired companies into the Ipsen QMS.
What We're Looking For
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Knowledge of GxP requirements and Quality Assurance within the pharmaceutical, biotechnology or medical device industry.
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Hands-on experience with an electronic Document Management System in a regulated GxP environment.
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Hands-on experience with Learning Management Systems and GxP training administration.
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Ability to connect, structure and analyse data from multiple sources and leverage digital tools such as Power BI, automation and AI-enabled solutions.
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Problem-solving skills, with the ability to assess compliance risks and determine appropriate corrective or improvement actions.
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Experience supporting Quality Systems improvement initiatives.
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Experience working in a Global or cross-functional environment and coordinating activities with multiple stakeholders.
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Bachelor's degree in Life Sciences, Quality or a related discipline, and fluency in English.
Why Join Ipsen?
This is an opportunity to work in a visible Global role with exposure across Quality, IT, HRIS, and business stakeholders. You'll help shape Quality processes, support digital transformation initiatives, and contribute to a culture focused on compliance, collaboration, and continuous improvement.
Ready to Make an Impact?
If you're passionate about Quality Systems, enjoy collaborating across Global teams, and want to help drive operational excellence in a purpose-led organisation, we'd love to hear from you.
Apply today and help us create innovative solutions that make a meaningful difference for patients worldwide.
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