Regional Quality Documentation Senior Specialist

About the job

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 including identify opportunities for format improvement: Format monitoring for alignment with local strategy, and 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 the documentation update process, with periodic review process, in support to local document governance

• Participate to local document governance meetings

• Coordinate gap assessment process: Monitoring of STD assessment and GOP Direct use decision: ensure progress of the process done by local SMEs with local doc Governance, report and KPI

• Prevent gap assessment process from other non-standardized approach

• For local document initiation: Creation of the Doc ID in QualiPSO and metadata - 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 sites/entities and internal client: Q&A redirection on doc content to experts : Direct questions to the appropriate authors and subject matter experts (SMEs) and providing expert responses, first level answer for simple questions (on doc processes), data extractions, report generation, questions about QualiPSO metadata

• Support DCR process – Monitor 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, and generate QualiPSO extraction on demand

About you

• Experience: >3 year professional experience in documentation, (optional: in GxP environment)

• Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments

• Technical skills: Strong skills in Quality DMS, Word, Excel, PowerPoint, Leadership of multinational teams

• Education: Bachelor or Master Degree

• Languages: Excellent English communication and writing