Global Quality Systems Specialist - Documentation & Training

Ipsen Pharma (SAS); Paris; Hybride; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Ipsen Pharma (SAS) is seeking a Global Quality Systems Specialist - Documentation & Training to own GxP document and training management. You will partner with Quality, IT, HRIS and other functions to ensure compliant, harmonised processes across Global Quality.

You will maintain eDMS and LMS, oversee training matrices and compliance, and contribute to continuous improvement and audits within Ipsen’s Quality Management System.

Qualifications

• Bachelor’s degree in Life Sciences, Quality or a related discipline.
• Experience with GxP and Quality Systems in pharmaceutical/biotech/medical devices.
• Hands-on with eDMS and LMS in regulated environments.
• Experience coordinating global/cross-functional activities.

Responsabilités

• Serve as expert for Global GxP document management and stakeholder guidance.
• Manage document lifecycle in eDMS: creation, revision, withdrawal.
• Coordinate periodic reviews of Global Quality procedures and cross-functional communications.
• Support eDMS administration, access, releases and testing.
• Act as LMS Administrator and Training Specialist; maintain training matrices and curricula.
• Monitor GxP training compliance and report insights to stakeholders.
• Support harmonisation of documentation and training across sites and functions.
• Assist audits by coordinating relevant Quality Systems information.

Connaissances

Stakeholder management

Communication

Organizational skills

Formation

Bachelor’s degree in Life Sciences/Quality

Outils

eDMS

LMS

Power BI

Description du poste

Global Quality Systems Specialist - Documentation & Training 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

At Ipsen, we are driven by one purpose: improving patients’ lives through innovation and specialty care. We are looking for a Global Quality Systems Specialist - Documentation & Training, to join our Global Quality team. In this individual-contributor role, you will provide operational expertise and take ownership of defined activities across GxP document and training management. You will support the relevant Global Business Process Owners and contribute to the compliance, harmonisation and continuous improvement of Ipsen’s Quality Management System. The role reports to the Global Quality Systems Director, and you will work closely with stakeholders across Quality, IT, HRIS and other business functions, providing specialist support and helping ensure effective, compliant and sustainable Quality Systems processes.

What You’ll Do

• Serve as a subject-matter expert and key operational point of contact for Global GxP document management activities, providing guidance and support to stakeholders.
• Manage document lifecycle activities within the electronic Document Management System (eDMS), including document creation, revision and withdrawal.
• Coordinate periodic reviews of Global Quality procedures and support the communication of cross-functional GxP documents.
• Support eDMS administration, access management, system enhancements, releases, testing and deployment activities.
• Act as LMS Administrator and Training Specialist for Global Quality, maintaining training matrices, learning objects, curricula and user profiles.
• Monitor GxP training compliance for the Global Quality team, provide reporting and insights to stakeholders, and coordinate follow-up activities where required.
• Contribute to the harmonisation of documentation and training practices across functions, entities and sites.
• Support audit and inspection activities by coordinating and providing relevant Quality Systems information and evidence.
• Provide specialist support in resolving Quality Systems issues, assessing associated GxP and compliance risks, and identifying appropriate corrective or improvement actions.
• Lead or contribute to defined Quality Systems improvement initiatives and support the integration of newly acquired companies into Ipsen’s Quality Management System.
• Partner with global and cross-functional stakeholders to support operational excellence across Global Quality.

What We’re Looking For

• Experience within the pharmaceutical, biotechnology or medical device industry.
• Good knowledge of GxP requirements and Quality Systems principles.
• Hands-on experience with electronic Document Management Systems (eDMS) within a regulated environment, ideally as a super user.
• Hands-on experience with Learning Management Systems (LMS) and GxP training administration.
• Experience supporting documentation, training process.
• Experience working across global or cross-functional teams and coordinating activities with multiple stakeholders.
• Strong organisational, communication and stakeholder management skills.
• Ability to investigate issues, assess GxP and compliance risks and contribute to practical solutions.
• Ability to analyse and interpret data, leveraging digital tools such as Power BI, automation and AI-enabled solutions.
• Experience contributing to continuous improvement initiatives.
• Bachelor’s degree in Life Sciences, Quality or a related discipline.
• Fluent English.

Why Join Ipsen?

At Ipsen, you’ll have the opportunity to work in a collaborative and international environment where your contribution makes a real impact. You will gain exposure across Global Quality, develop your expertise in Quality Systems and play an important role in supporting a culture of quality, compliance 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 At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society.