Back to Jobs

Quality Documents Expert

Sanofi (US)
Morristown, NJ
Job Title: Quality Documents Expert

Location : Morristown, NJ Cambridge, MA

About the Job

Join the engine of Sanofi’s mission - where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.

The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and culturally diverse team.

The Quality Documents Expert participates to the robustness of the quality system by supporting the Quality Documentation.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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

Major duties and 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:
    • - 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

About You

About You

Qualifications:
  • Bachelor’s degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree)
  • 2+ years’ experience in GxP Quality system management, Quality Documents or Medical/Scientific writing
  • 2+ years’ experience in Pharmacovigilance and/or medical activities
  • Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
  • Advanced use of Microsoft Word® and Excel®
  • Advanced use of Content Management System (CMS)
  • Use and develop dashboards
  • Project Management skills

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

Why Choose Us

  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 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, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG
#LI-GZ

#LI-Onsite
#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Posted 2026-01-12

Recommended Jobs

Hadoop Admin (Kafka)

Two95 International Inc.
Newark, NJ

Title: Hadoop Admin (Kafka) Location: NJ (Near Newark) Job Type: Contract to Hire Salary: $Market (Based on the Experience) + Benefits Client: F500 Requirements Requiremen…

View Details
Posted 2025-08-09

Seasonal - Fast Food Cashier - Food Truck

Ocean Casino Resort
Atlantic City, NJ

The Fast Food Cashier is responsible for processing guest orders, handling cash and bagging orders in an accurate and efficient manner. Position Responsibilities Responsible for register b…

View Details
Posted 2025-04-02

Clerical Assistant

Earth Treasures Jewelers
Eatontown, NJ

Clerical Assistant Location Eatontown, NJ : About Us: Overview: The excitement that we have for jewelry at Earth Treasures has been consistent since 1974 when the business began. Our employees are …

View Details
Posted 2026-01-09

Mental Health Associate

1 CLARA MAASS DRIVE
Belleville, NJ

Job Title: Mental Health Associate Location: Clara Maass Medical Center Department Name: Psychiatry Req #: 0000220995 Status: Hourly Shift: Evening Pay Range: $21.90 - $27.42 per hou…

View Details
Posted 2025-11-24

Brokerage Ops Support Specialist

NFI Industries
Camden, NJ

Overview: The Brokerage Operations Support Specialist is an entry level position, providing operational support to the customer and carrier account managers. These activities include responding to …

View Details
Posted 2025-11-03

Senior Marketing Strategic Partnership Manager

moomoo
Jersey City, NJ

Futu US Inc. stands at the forefront of financial services, housing two SEC registered broker-dealers alongside a cryptocurrency brokerage — all operating under the reputable wing of Futu Holdings …

View Details
Posted 2025-08-18

Assistant Director of Financial Aid

Stevens Institute of Technology
Hoboken, NJ

Job Description The Assistant Director of Financial Aid, under the direction of the Senior Director of Financial Aid, provides assistance to prospective and enrolled students and their families in…

View Details
Posted 2025-12-18