Global Quality Systems Manager

Ipsen; Dreux; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Ipsen Pharma recherche un Global Quality Systems Manager pour piloter les documents GxP et la gestion de la formation au sein du QMS mondial. Vous assurerez l’expertise et le leadership dans la gestion documentaire et la formation, en lien avec les responsables Process et les sites globaux.

Le poste nécessite une connaissance GxP, une expérience LMS et une capacité à analyser des données via des outils numériques comme Power BI, avec une approche transversale au niveau international.

Qualifications

• Connaissance GxP et assurance qualité dans pharmaceutique/biotechnologie ou dispositifs médicaux.
• Expérience pratique avec un DMS électronique en environnement GxP.
• Expérience LMS et gestion formation GxP.

Responsabilités

• Servir d’expert GxP et Document Manager au sein du système QMS mondial.
• Gérer les activités documentaires GxP et communiquer les documents cross-fonctionnels mensuellement.
• Administrer LMS et formations Global Quality, maintenir matrices et profils utilisateurs.
• Assurer le suivi de la conformité formation GxP et harmoniser pratiques documentaires et formations entre fonctions et sites.
• Conduire ou soutenir des initiatives d’amélioration des Systèmes de Qualité et intégrer des acquisitions au QMS Ipsen.

Connaissances

GxP knowledge

Training administration

Data analysis

Cross-functional collaboration

Problem solving

Formation

Bachelor’s degree in Life Sciences/Quality

Outils

Electronic Document Management System

Power BI

Automation tools

AI-enabled solutions

Description du poste

Title:

Global Quality Systems Manager

Company:

Ipsen Pharma (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at **https://www.ipsen.com/**and follow our latest news on LinkedIn and Instagram.

Job Description:

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

• 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.
• Manage key Global Quality documentation activities, including the periodic review of GxP procedural documents and the monthly communication of Global cross-functional GxP documents.
• Act as LMS Administrator and Training Specialist for Global Quality, maintaining training matrices, Learning Objects, curricula and user profiles.
• Monitor Global Quality GxP training compliance and support the harmonization of documentation and training practices across functions, entities and sites.
• 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

• Knowledge of GxP requirements and Quality Assurance within the pharmaceutical, biotechnology or medical device industry.
• Hands-on experience with an electronic Document Management System in a regulated GxP environment.
• Hands-on experience with Learning Management Systems and GxP training administration.
• Ability to connect, structure and analyse data from multiple sources and leverage digital tools such as Power BI, automation and AI-enabled solutions.
• Problem-solving skills, with the ability to assess compliance risks and determine appropriate corrective or improvement actions.
• Experience supporting Quality Systems improvement initiatives.
• Experience working in a Global or cross-functional environment and coordinating activities with multiple stakeholders.
• 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.

#LI-Hybrid

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l’inclusion et de l’égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d’aménagements ou d’aide pendant le processus de candidature, veuillez en informer l’équipe de recrutement. Ces informations seront traitées avec soin et n’auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même