Deviation and CAPA Specialist Business System Owner

Sanofi; Toronto; On-site; CAD 76,000 - 110,000; Full time

Job summary

Sanofi is seeking a Deviation & CAPA Specialist Business System Owner for the Toronto site on a fixed-term 18 months. The role supports the BSO in managing Deviation and CAPA processes, ensures quality systems compliance, and contributes to site-wide training and global regulatory alignment.

The position operates within a global biopharma environment, emphasizing collaboration with cross-functional teams to monitor KPIs, support audits, and drive continuous improvement in quality systems and

Qualifications

• Experience in quality systems management and CAPA processes.
• Strong data analysis skills and attention to detail.
• Ability to develop and deliver training materials.

Responsibilities

• Support the BSO Manager in owning the Deviation and CAPA processes for the site.
• Conduct regular data quality checks and validations to identify issues.
• Assist in developing and delivering training programs and practices.
• Identify risks related to processes and support mitigation strategies.
• Support continuous improvement initiatives aligned with global processes.

Skills

Quality systems

Data analysis

Training delivery

Cross-functional collaboration

Job description

R2867485 Deviation & CAPA Specialist Business System Owner Duration: Fixed Term, 18 months 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. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. In this position, the incumbent supports the Business System Owner (BSO) Manager in the administration of the Deviation and CAPA quality system processes supporting the Manufacturing & Supply teams at the Toronto site. The role assists in ensuring that the identified quality systems are developed, monitored, and improved to maintain the site in full compliance. The role also supports site‑wide training for the associated programs and helps ensure that procedures are aligned to global quality and regulatory requirements.

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 Business System Owner Manager in the ownership of the quality Deviation and CAPA processes for the site, including process, system, and data
• Conducting regular routine data quality checks and validations to identify and address any process, system, or data issue
• Assisting in the development and delivery of training programs, principles and practices
• Identifying and assessing risks related to the processes in scope and supporting the implementation of mitigation strategies
• Supporting continuous improvement initiatives on site, in line with global processes and practices
• Assisting in overseeing the computerized systems associated with the Deviation and CAPA processes to ensure they meet all requirements
• Monitoring key performance indicators in line with global guidance
• Supporting site representation in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
• Ensuring deviation and CAPA management processes are supported by appropriate procedures, which are implemented and maintained locally
• Involving cross‑functional teams to address and resolve deviations and CAPAs
• Analyzing deviation and CAPA data to identify trends and potential areas for improvement
• Supporting the audit and inspection process by providing required information related to deviation and CAPA management
• Ensuring process performance with other entities/sites involved in the management of deviations and CAPAs at the site level
• Supporting Complaints, as required

Key Involvement in Decision Making Process

• Support the establishment and prioritization of process evolutions for the site (C)
• Support the definition of initiatives to maintain and improve quality processes and systems (C)
• Support audits and inspections and assist in presenting the process to auditors and inspectors (A)
• Support senior management on regulatory strategies and compliance issues (I)
• Support the implementation of remediation actions from findings from internal and external audits (I)
• Support the identification of training needs (I)
• Is informed of inspections and audit outcomes (I)

HSE Requirements

Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

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.

We welcome and encourage applications from all qualified applicants.

Accommodations for persons with disabilities required during the recruitment process are available upon request.

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.

Equal Opportunity / EEO Declaration

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.

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

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)LINKOR (US) LINK.

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.