Quality Documents Expert

Role Summary

Quality Documents Expert in the Pharmacovigilance Quality (PVQ) department within PSPV, supporting the robustness of the quality system through Quality Documentation. Based in Morristown, NJ and Cambridge, MA, the role involves international collaboration to ensure quality documents meet global standards and are properly managed throughout their lifecycle.

Responsibilities

• Support Pharmacovigilance, Medical and Transversal Quality Operations quality documentation and related training
• Promote harmonization of quality standards
• Communicate processes and tools related to quality documentation
• Prepare and maintain Pharmacovigilance and Medical Quality documents in line with global quality standards
• Contribute to the establishment and monitoring of the annual Quality Documents plan and apply the Sanofi QD architecture
• Foster simplification and avoid redundancy of Quality Documents
• Ensure timeliness and quality of Quality Documents in the Content Management System (CMS)
• Ensure documents follow correct workflow steps and perform technical reviews for writing rules
• Monitor workflow steps until approval; remind authors, reviewers and authorizers as needed
• Communicate on approval and effective dates of Quality Documents
• Deliver training for Quality Documents by creating LMS training links and preparing e-learning material with SMEs
• Lead or participate in projects related to process or tools improvements; assess impacts and monitor action plans
• Maintain up-to-date documentation describing Quality Documents activities
• Perform gap assessments on Global QDs and follow up CAPA plans
• Provide guidance and support to countries on managing local QDs
• Contribute to Quality Documents metrics and KPI reporting
• Support inspections and audits by providing required data, participating in interviews, contributing to RCA and CAPA proposals
• Collaborate with key stakeholders from the Quality Document network

Qualifications

About You

• Required: Bachelor’s degree (e.g., Nursing, Pharmacist, Health Science)
• Required: 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: Ability to use and develop dashboards
• Required: Project Management skills

Preferred

• Team player who cooperates transversally in a cross-functional environment
• Analytic, proactive, and problem-solving mindset
• Self-motivated, able to prioritize, plan effectively and autonomously
• Organized and detail-oriented while seeing the big picture
• Efficient time management
• Customer focus

Skills

• GxP Quality systems
• Quality Documentation management
• CMS proficiency
• Training development and LMS administration
• Documentation governance and KPI reporting
• Technical writing and document review
• RCA/CAPA collaboration

Education

• Bachelor’s degree (e.g., Nursing, Pharmacist, Health Science)