Sanofi
RegionalQualityDocumentationSrSpecialist
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“Regional Quality Documentation Sr Specialist at Sanofi. Skills: documentation, governance, process improvement, stakeholder management. Execute administration and governance tasks. Identify opportunities for format improvement”
What You'll Achieve.
increase reusability & interoperability; accelerate impact on global health
Industry & Context.
problem-solving; analytical skills
What They're Looking For.
Must Have
+3 years of professional experience in documentation, Bachelor or Master Degree, English level advance
Nice to Have
in GxP environment, French and/or Portuguese would be a plus
What You'll Do.
Execute administration and governance tasks
Identify opportunities for format improvement
Identify opportunities for process improvement
Understand document applicability and stakeholders
Manage documentation update process
Participate in local document governance meetings
Coordinate gap assessment process
Generate QualiPSO extractions on demand
How You'll Work.
Team & Collaboration
work collaboratively with cross-functional teams
Full Job Description
Job title: Regional Quality Documentation Sr Specialist * Location: Bogotá 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. Main responsibilities: Execute administration and governance related tasks: * Identify opportunities for format improvement: Format monitoring for alignment with local strategy. * Identify opportunities for process improvement: interaction with local Doc Governance team, and support to doc strategies * Understand the applicability of the documents and stakeholders, challenge the stakeholders, review stakeholder list & manage list for review and distribution * With a focus on initiation of quality documents (QD) workflow management: share all information needed: 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
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