Sanofi · 1 day ago
Quality Documents Expert
Cambridge, MA
Full-time
Onsite
Entry, Mid Level
2+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Quality Documents Expert is responsible for supporting the Pharmacovigilance Quality documentation and ensuring compliance with global quality standards while promoting harmonization of quality processes.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Supporting the Pharmacovigilance, Medical and Transversal Quality Operations (TQO) quality documentation (QD) and its related training
Promoting harmonization of quality standards
Communicating on processes and tools related to quality documentation
Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QDs) in line with global quality standards
Promote a single consistent approach in sanofi processes:
Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied
Foster simplification and avoid redundancy of Quality Documents
Ensure timeliness and quality of Quality documents in the Content Management System (CMS):
Ensure documents are following the correct workflow steps
Perform a technical review of each document ensuring writing rules are followed
Monitor workflow steps of each document until approval. Remind authors, reviewers and authorizer as needed
Communicate on the approval and effective dates of Quality Documents
Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs
Lead or participate to specific projects related to process or tools improvements, assess impacts, set up and monitor action plans
Maintain up-to-date the documentation describing Quality Documents activities
Perform gap assessments on Global QDs and follow-up Corrective Actions and Preventive Actions (CAPA) plan
Provide guidances and support to countries on the management of their local QDs
Contribute to the preparation and communication of Quality Documents metrics and Key Performance Indicators (KPI)
Support inspections and audits by providing required data on due time, participating to interviews, contributing to Root Cause Analysis (RCA) and CAPA proposal
Collaborate with key stakeholders from Quality Document network
Qualification
Required
Bachelor's degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree)
2+ years' experience in GxP Quality system management, Quality Documents or Medical/Scientific writing
2+ years' experience in Pharmacovigilance and/or medical activities
Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
Advanced use of Microsoft Word® and Excel®
Advanced use of Content Management System (CMS)
Use and develop dashboards
Project Management skills
Preferred
Team player that cooperates transversally in a cross-functional environment
Analytic, proactive, and problem-solving mindset
Self–motivated, able to relentlessly prioritize, plan effectively and autonomously
Organized and detail oriented while seeing the big picture
Efficient time management
Customer focus
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase