Quality Documents Expert

About the Job

Sanofi seeks a Quality Documents Expert in its Pharmacovigilance Quality department. The role supports quality documentation, harmonization of standards, and training within an international, culturally diverse team.

Quality Documents Expert

Morristown, NJ;
Cambridge, MA

• Support pharmacovigilance, medical and transversal quality operations documentation and related training.
• Promote harmonization of quality standards.
• Communicate on processes and tools related to quality documentation.

• Ensure preparation and maintenance of pharmacovigilance and medical quality documents in line with global standards.
• Promote a single consistent approach in Sanofi processes, including contributing to the annual QD plan and simplifying documents.
• Ensure timeliness and quality of QDs in the CMS, monitor workflow, perform technical reviews and communicate approval dates.
• Deliver training for QDs via LMS and e‑learning material.
• Lead or participate in projects for process or tool improvements.
• Maintain documentation describing QD activities and perform gap assessments.
• Support inspections and audits by providing data and participating in RCAs and CAPA proposals.
• Provide guidance to countries on local QDs.
• Contribute to QD metrics and KPIs.
• Collaborate with key stakeholders.

• Bachelor’s degree (e.g., Nursing, Pharmacist, Health Science).
• 2+ years in GxP quality system management, quality documents, or medical/scientific writing.
• 2+ years in pharmacovigilance and/or medical activities.
• Knowledge of GVP, GCP, ICH.
• Advanced proficiency in Microsoft Word and Excel.
• Advanced proficiency with CMS.
• Experience developing dashboards.
• Project management skills.

• Team-oriented, cross‑functional collaboration.
• Analytical, proactive problem solving.
• Self‑motivated with strong prioritization, planning and autonomy.
• Organized, detail oriented, sees big picture.
• Time‑management efficiency.
• Customer focus.

• Supportive, future‑focused team.
• Opportunities to grow locally or internationally.
• Rewards package that recognizes contributions and amplifies impact.
• Health and wellbeing benefits, including high‑quality healthcare and 14 weeks gender‑neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.