Quality Documents Expert

Role Summary

The Quality Documents Expert supports the Pharmacovigilance Quality (PVQ) department within the Patient Safety & Pharmacovigilance (PSPV) function. Based in Morristown, NJ and Cambridge, MA, this role strengthens the quality system by ensuring robust quality documentation and processes across global operations.

Responsibilities

• 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 and contribute to the establishment and monitoring of the annual QD plan
• Foster simplification and avoid redundancy of Quality Documents
• Ensure timeliness and quality of Quality Documents in the Content Management System (CMS): follow correct workflow steps, perform technical reviews, monitor workflow until approval, and communicate on approval and effective dates
• Deliver training for Quality Documents by creating training links in Learning Management Systems and preparing e-learning material with SMEs
• Lead or participate in projects related to process or tools improvements, assess impacts, set up and monitor action plans
• Maintain up-to-date documentation describing Quality Documents activities
• Perform gap assessments on Global QDs and follow up on CAPA plans
• Provide guidance and support to countries on managing their local QDs
• Contribute to the preparation and communication of Quality Documents metrics and KPIs
• Support inspections and audits by providing required data on time, participating in interviews, contributing to RCA and CAPA proposals
• Collaborate with key stakeholders from the Quality Document network

Qualifications

• Required: Bachelor’s degree (e.g., Nursing, Pharmacist, Health Science) and 2+ years’ experience in GxP Quality system management, Quality Documents or Medical/Scientific writing
• Required: 2+ years’ experience in Pharmacovigilance and/or medical activities
• Required: Knowledge of International Pharmaceutical Regulation (GVP, GCP, ICH)
• Required: Advanced use of Microsoft Word and Excel
• Required: Advanced use of Content Management System (CMS)
• Required: Use and development of dashboards
• Required: Project Management skills
• Preferred: Team player with cross-functional collaboration
• Preferred: Analytic, proactive, and problem-solving mindset
• Preferred: Self-motivated, able to prioritize, plan effectively and autonomously
• Preferred: Organized, detail-oriented, with big-picture thinking
• Preferred: Efficient time management and customer focus

Skills

• Quality documentation management
• CMS (Content Management System) proficiency
• Learning Management System (LMS) usage and e-learning material development
• Documentation workflow and technical writing
• Data analysis and dashboard development
• Process improvement and project management

Education

• Bachelor’s degree in a health-related field (e.g., Nursing, Pharmacy, Health Science)