Quality Documents Expert

Role Summary

The Quality Documents Expert supports Pharmacovigilance Quality (PVQ) documentation and related training to ensure alignment with global quality standards. Based in Morristown, NJ and Cambridge, MA, you will collaborate within an international team to maintain Quality Documents (QDs) and continuously improve the quality system.

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

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

Skills

• Quality documentation management
• Content Management System (CMS) proficiency
• Microsoft Word and Excel proficiency
• Dashboards development and use
• Project management