Toronto, ON
Full time
R2871503
**Reference no. R2871503**
**Position title:**
Quality Assurance Specialist
**Department:**
QA DS B89/90
**Location:**
Toronto, ON
**About the job**
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale.

In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
**Our Team/ Overview:**
The Quality Assurance team serves as a critical guardian of patient safety and product excellence through rigorous GMP record review and batch release activities, while fostering a culture of quality ownership and continuous improvement across operations.

Through systematic oversight and shopfloor expertise, we proactively identify and mitigate quality risks, maintain robust quality systems, and ensure full regulatory compliance.

Our collaborative partnerships across all functions embed quality principles into every aspect of operations, enabling the timely delivery of high-quality products to patients while upholding the highest standards of operational excellence.
**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:**
Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
Conducting regular audits of production processes to identify and address potential quality issues
Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
Managing and resolving quality-related issues in a timely and effective manner
Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
Leading root cause analysis investigations for quality incidents and implementing preventive measures
Participating in internal and external audits and regulatory inspections providing support and documentation
Developing and implementing risk management strategies to mitigate potential quality issues
Fostering a culture of quality and continuous improvement across the organization
**Section 3: Key Involvement in Decision-Making Process**
**Key Roles (D,A,I)**
Request corrections when GMP rules are not respected (D)
Prioritize quality and compliance objectives (A)
Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
Request quality improvement initiatives and strategies (D)
Identify discrepancies and corrective/preventive actions that need to be taken (D)
Escalate to upper management any failure in GMP execution on shopfloor (I)
Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
Advise on how to present a topic and answer specific questions (A)
Advise on risk management strategies and plans (A)
Advise on initiatives to promote a quality-focused culture (A)
**Section 4: Local specificities**
**Additional Accountabilities**




Provide QA support to any required APU or PCU on site as designated by the QA Ops Manager & PCU Lead
Any other duties that may arise as required
**About you**
**Education / Experience Requirements:**
Bachelor's degree or higher preferably in Pharmacy, Chemistry, Biochemistry, Life Sciences, Chemical Engineering, or a related scientific field
Minimum 2 years of experience in pharmaceutical quality assurance or operations (depending on level)
**Technical Skills:**
Demonstrated experience in Drug Substance / Drug Product (DP) quality operations
Working knowledge of cGMP and GxP regulations in a regulated pharmaceutical environment
Experience with quality documentation, compliance activities, and regulatory requirements
Familiarity with change control processes and quality systems
Background in process improvement and quality investigations
Quality Assurance and Change Control Processes
Inspection Readiness
Root Cause Analysis / RCA / Preventive Action
Regulatory Requirements
QA Standards
Documentation Review
Manufacturing Processes
Product Quality Assurance
Risk Management
Cross-Team Communication and Collaboration
Stakeholder Management
**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.
**This position is for a current vacant role that is now open for applications.​**
**AI Usage**
"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,
Data Subject Rights Webform .

The
Data Subject Rights Webform




can also be used to request 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
#GD-SP ​
#LI-SP
#LI-Onsite
**Pursue**
**_progress_**
**, discover**
**_extraordinary_**
Better is out there.

Better medications, better outcomes, better science.

But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s)
and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
_North America Applicants Only_
The salary range for this position is: 76,200.00 - 110,100.00
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINK (https://myflex-benefits.ca/en/home/) OR (US) LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

La fourchette salariale pour ce poste est la suivante: 76,200.00 - 110,100.00
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents.

Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien (https://myflex-benefits.ca/fr/home/)
We are an R&D; driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth.

Our team is guided by one purpose: we chase the miracles of science to improve people's lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting
www.sanofi.com
or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
Start a career that makes a difference.

Reinvention is in our DNA.

It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies.

Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities.

This is where you grow your career.

We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.

📌 Quality Assurance Specialist (Toronto)
🏢 Sanofi Group
📍 Toronto