Quality Control Maintenance and Qualification Specialist

Sanofi; Toronto; On-site; CAD 69,000 - 110,000; Full time

Benefits offered by this job

Health and wellbeing benefits

Career growth opportunities

Job summary

Sanofi in Toronto, ON, is seeking a Quality Control professional to support the Site Quality Operations. You will execute maintenance and qualification on lab equipment, write and review related documentation, and ensure regulatory alignment with FDA/EMA standards.

Ideal candidates have a Bachelor’s in science/engineering, 1 year in qualification activities, and 1 year in quality control. The role emphasizes collaboration with engineering and suppliers to sustain lab performance.

Qualifications

• Bachelor of Science, Engineering, or related field required.
• 1 year of qualification activities experience in pharma/biotech.
• 1 year of quality control experience.
• Strong regulatory understanding (FDA/EMA) related to qualification.
• Ability to manage multiple qualification projects and timelines.

Responsibilities

• Execute maintenance and qualification protocols in the area.
• Create or review maintenance/qualification docs (protocols, reports, risk assessments, traceability matrices).
• Escalate quality or HSE events related to lab equipment promptly.
• Ensure documentation of deviations, non-conformances, and corrective actions.
• Evaluate validation changes for scope-related change controls.
• Comply with regulatory requirements and company quality standards.
• Collaborate with engineering and external suppliers to execute validation activities.
• Identify opportunities to improve maintenance and qualification processes.
• Perform routine and preventive maintenance and qualification on equipment/systems.
• Troubleshoot and repair equipment to minimize downtime.
• Maintain accurate records of maintenance/qualification activities.

Skills

Quality control

Analytical testing

Documentation

Regulatory understanding

Cross-functional collaboration

Education

Bachelor of Science / Engineering or related field

Job description

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 Control Team is part of Site Quality Operations supporting the Manufacturing & Supply organization in Toronto. The Quality Control team oversees analytical testing, product release, method validation, stability programs, and laboratory operations in alignment with regulatory requirements and Sanofi standards. The team drives continuous improvement and operational excellence initiatives to enhance laboratory efficiency, analytical capabilities, and quality systems performance.

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

• Executing the maintenance and qualification protocols in their area
• Writing or reviewing the maintenance and qualification documentation, when not executing; this includes protocols, reports, risk assessments, and traceability matrices according to predefined timelines
• Informing their manager of any quality or HSE event related to lab equipment in a timely manner to ensure investigation and impact assessment are performed appropriately
• Ensuring proper documentation of deviations, non-conformances, and corrective actions
• Ensuring proper evaluation (validation expertise) of change controls related to his/her scope
• Ensuring all maintenance and qualification activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards
• Cooperating with cross-functional teams, including engineering and external suppliers, to ensure smooth execution of validation activities
• Identifying opportunities for improving maintenance and qualification processes and contributing to continuous improvement initiatives
• Performing routine and preventive maintenance and qualification on equipment and systems to ensure optimal performance and reliability
• Troubleshooting and repairing equipment and systems as needed to minimize downtime and ensure continuous operation
• Maintaining accurate records of maintenance and qualification activities, including work orders, maintenance logs, and calibration records

Key Involvement in Decision-Making Process

Execute or coordinate the maintenance and qualification plans for the lab equipment. Responsible for performing routine and preventive maintenance and qualification on equipment and systems.

About you

A Bachelor of Science, Engineering, or related field 1 year of experience in qualification activities within the pharmaceutical or biotechnology industry 1 year of experience in quality control Proficiency in preparing maintenance and qualification documentation Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to qualification Ability to manage multiple qualification projects simultaneously, ensuring they are completed on time and within budget Excellent communication skills to effectively collaborate with cross-functional teams.

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 new 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

North America Applicants Only

The salary range for this position is: 69,200.00 - 110,000.00 (Includes target bonus) 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)LINKOR (US) LINK.

La fourchette salariale pour ce poste est la suivante: 69,200.00 - 110,000.00 (Comprend le bonus cible) 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

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 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.