Deviation and CAPA Specialist Business System Owner

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.

About you

Education/Certifications:

• Bachelor's degree

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. 

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.

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.