Deviation and CAPA Specialist Business System Owner

BioTalent Canada; Toronto; On-site; CAD 80,000 - 105,000; Full time

Job summary

Sanofi in Toronto is seeking a quality systems professional to support Deviation and CAPA processes across the site. You will ensure programs align with global quality and regulatory requirements and contribute to site-wide training and documentation enhancements.

The role requires 2–5 years of quality management experience in pharma, with strong attention to detail and the ability to collaborate across cross-functional teams.

Qualifications

• Ability to meticulously review and manage quality system documents.
• Strong organizational skills to support documentation projects and timelines.
• Excellent written and verbal communication to collaborate across departments.

Responsibilities

• Support the Business System Owner in Deviation and CAPA processes for the site.
• Run regular data quality checks to identify and address issues.
• Assist in training program development and delivery for related programs.
• Identify risks in processes and help implement mitigation strategies.
• Support continuous improvement initiatives in line with global processes.
• Oversee computerized systems for Deviation and CAPA to ensure compliance.
• Monitor KPIs according to global guidance.
• Engage cross-functional teams to address deviations and CAPAs.

Skills

Document control

Organizational skills

Communication skills

Data analysis

Job description

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.

About you

Education/Certifications:

Expected Experience:

2-5 years of experience in quality management systems in the pharmaceutical industry, including in the development, review, and approval of quality system documents

Expected Technical Skills:

• Ability to meticulously review and manage documents to ensure accuracy, completeness, and compliance with regulatory standards
• Strong organizational skills to support documentation projects, including timelines, resources, and deliverables
• Excellent written and verbal communication skills to effectively convey information and collaborate with various departments
• Ability to analyze complex information, identify trends, and support data-driven decisions to improve documentation processes

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, 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.

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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.