Quality Documents Expert
Company: Sanofi
Location: Morristown
Posted on: January 5, 2026
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Job Description:
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.
Keywords: Sanofi, Wilmington , Quality Documents Expert, Science, Research & Development , Morristown, Delaware
