Business System Expert H/F - 78

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

At Excelya, we are dedicated to shaping the future of healthcare, and we invite you to be a part of our dynamic team as a Business System Expert. This key position offers you the chance to leverage your expertise to enhance business processes, drive systems optimization, and support our growth as a leading mid-size CRO.

In this role, you will work closely with stakeholders to understand their needs, analyze business requirements, and design solutions that facilitate efficiency and effectiveness within our operational landscape.

Main Responsibilities

- Ensure high performance and proper functioning of information systems supporting Document & Referential Management (Veeva eTMF & SharePoint)
- Monitor, track, and follow up on technical issues with DDIS and coordinate resolution with IS teams, providers, and QA
- Represent user needs and act as liaison between system users and IT stakeholders to ensure systems evolve in line with operational requirements
- Maintain up-to-date quality documentation related to system validation, usage, and compliance (ICH-GxP)
- Ensure proper user training, provide guidance, and support teams in system use
- Participate in system deployments, upgrades, and validation activities, including drafting validation documents and executing tests
- Oversee operational system activities, including administrative tasks and centralized workflows within Veeva eTMF and SharePoint
- Monitor system usage and compliance, identify deviations, and propose corrective and preventive actions (CAPA)
- Collaborate closely with the Business System Expert (BSE) team to ensure aligned processes and consistent system oversight
- Produce required deliverables, including validation documentation, OQ test reports, weekly support activity reports, CAPA proposals, and meeting minutes