The B100 Compliance Professional will manage projects affecting the B100 Manufacturing in relation to compliance commitments and continuous improvement projects. This role will also act as a diversified technical person who works within the Quality Systems to support B100 Manufacturing in the context of change control lead/ super user, CAPA closure, and support with event investigations.

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:
1. Quality/ Project Management Support (40%):

Provide project management support on compliance related activities and continuous improvement projects specific to B100 Platforms or Bulk Manufacturing, with the aim to close gaps within the required timeframe and ensure uninterrupted production activities

B100 Bulk representative for Site Wide Initiatives projects related to Quality Systems, Processes and Procedures

Perform and/or participate in GQD gap analysis for the B100 Bulk Manufacturing Department

Implements Corrective and Preventative Actions established as B100 commitments in response to Internal/ Global or Regulatory Audits

Identify opportunities for alignment across the B100 platform applying LEAN methodologies

Facilitate and lead compliance meetings, as required

2. Change Control and CAPA Lead / Super User (30%):

Initiate and manage change control requests affecting the Bulk Manufacturing department

Collaborate with assessors for evaluation of changes

Ensure timely closure of change controls

Support Lead Investigators and B100 Platform in establishing change controls and/or CAPAs approved for execution in a very short timeframe to support closure of Deviations

3. Technical Writing and Reviewer (20%):

Update, review, and approve GMP documents such as SOPs, SWIs, protocols, reports

Coach and oversee technical writing as needed

Prepare and present Metrics reports for the B100 Platform

Lead Investigator support to collect data and investigate for deviations affecting the B100 platform





Collaborate transversally (QO, TS, MTECH, SME, QC etc.) to support the investigation

In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause

Scope and dimensions:
Breadth of responsibility (global/regional/country/site):

Site

About You
Education and Experience:

Minimum bachelor’s degree with 1-3 years of experience.

Consistently demonstrate Sanofi Play to Win behaviors; stretch, take action, act for patients and customers, and think Sanofi first.

Key Technical Competencies and Soft Skills:

Efficiently use company tools such as SAP, Phenix, Qualipso, etc. and the ability to adapt to new tools

Solid interpersonal skills

Ability to lead projects

Strong verbal and written communication skills.

Prepare timely Quality Metric reports.

Strong verbal and written communication skills.

Previous pharmaceutical and/or laboratory experience is preferred.

Must be legally entitled to work in Canada.

Ability to work transversally across functions.

Ability to work transversally across functions/departments and strong teamwork within the HSE team.

Strong attention to detail and analytical skills.

Excellent communication and interpersonal skills.

Technical writing, Presentation.

This position is for a new vacant role that we are actively hiring for.

“Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision‑making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring,



ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,can also be used torequest access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

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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.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done‑before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

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📌 Compliance Professional (Ontario)
🏢 BioTalent Canada
📍 Ontario