Sanofi
RegionalQualityDocumentationSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regional Quality Documentation Specialist at Sanofi. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. initiation of quality documents (QD) workflow management. Identify authors, applicable templates sharing, document change request (DCR) communication if applicable, draft generation in QualiPSO (ID, metadata creation), final draft cleanup before approval”
Industry & Context.
problem-solving; analytical skills
What They're Looking For.
Must Have
Professional experience in documentation, Bachelor’s or Master’s Degree in life sciences, Excellent English communication and writing
Nice to Have
Experience in GxP environment is an advantage, Knowledge of Quality DMS, is an advantage
What You'll Do.
initiation of quality documents (QD) workflow management
applicable templates sharing
document change request (DCR) communication if applicable
draft generation in QualiPSO (ID
final draft cleanup before approval
Manage and monitor the documentation update process
with periodic review process
in support to local document governance
Participate to local document governance meetings
Coordinate and prevent gap assessment process from other non-standardized approach
Manage the creation and update of metadata
understand the applicability of the documents/stakeholders
challenge the stakeholders
& implement communication strategy based local doc governance
Support document change request (DCR) process – support monitoring DCR process including pre-assessment & support doc update according to CR process
Prevent Change Request process from other non-standardized approach
Support communication on Global Quality Document approval
How You'll Work.
Team & Collaboration
cross-functional teams
Communication Scope
Excellent English communication and writing
Full Job Description
* Job title: Regional Quality Documentation Specialist * Location: Budapest, Hungary * Job type: Permanent, full time * Hybrid working (60% office, 40% home) **About the job** **Our Team:** Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. **_Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting._** **Main responsibilities:** * Focus on initiation of quality documents (QD) workflow management: Identify authors, applicable templates sharing, document change request (DCR) communication if applicable, draft generation in QualiPSO (ID, metadata creation), final draft cleanup before approval. * Manage and monitor the documentation update process, with periodic review process, in support to local document governance. * Participate to local document governance meetings. *
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