Quality Documents Expert

Role Summary

The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function, working in an international and culturally diverse team. You will support the robustness of the quality system by supporting Quality Documentation. Location: Morristown, NJ; Cambridge, MA.

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

Qualifications

• Required: Bachelor’s degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree)
• 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 in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
• Required: Advanced use of Microsoft Word and Excel
• Required: Advanced use of Content Management System (CMS)
• Required: Use and develop dashboards
• Required: Project Management skills

Education

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

Skills

• Quality documentation management
• Process improvement and documentation workflow management
• Training coordination and e-learning material development
• Cross-functional collaboration and stakeholder communication