Global Quality Systems Specialist - Documentation & Training

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 70,000 - 90,000; Full time

Job summary

Ipsen Pharma (SAS) is seeking a Global Quality Systems Specialist - Documentation & Training to own GxP document and training management in a multinational setting. You will support Global Business Process Owners and help harmonise Ipsen's Quality Management System across sites.

The role blends hands-on documentation and training activities with collaboration across Quality, IT, HRIS and other functions, driving continuous improvement and digital transformation within Global Quality.

Qualifications

• Bachelor's degree in Life Sciences, Quality or a related discipline.
• Experience with pharmaceutical/biotech/medical device industries preferred.
• Hands-on experience with eDMS in a regulated environment (super user preferred).
• Experience with LMS administration and GxP training management.

Responsibilities

• Serve as subject-matter expert for Global GxP document management.
• Manage document lifecycle in the electronic Document Management System (eDMS).
• Coordinate periodic reviews of Global Quality procedures.
• Support eDMS administration, access management, and deployments.
• Act as LMS Administrator and Training Specialist for Global Quality.
• Monitor GxP training compliance and provide stakeholder reports.
• Harmonise documentation and training practices across sites.

Skills

GxP knowledge

Quality systems

LMS administration

eDMS usage

Cross-functional collaboration

Data interpretation

Stakeholder management

Education

Bachelor's degree in Life Sciences/Quality

Tools

eDMS

LMS

Power BI

Job description

Title:

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!

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

Reporting to the Global Quality Systems Director, you will work closely with stakeholders across Quality, IT, HRIS and other business functions, providing specialist support and helping to ensure effective, compliant and sustainable Quality Systems processes.

This is an exciting opportunity to work in a global environment, combining hands-on Quality Systems responsibilities with stakeholder collaboration, continuous improvement and digital transformation initiatives.

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 i