Quality Deviation & CAPA Systems Lead

Biopharma Careers; Toronto; On-site; CAD 105,000 - 152,000; Full time

Job summary

Sanofi in Toronto is seeking a Deviation & CAPA Specialist Business System Owner to support the Deviation and CAPA quality system processes at the site, ensuring compliance with global quality and regulatory requirements. The role includes data quality checks, training delivery, risk assessment, and cross-functional collaboration across the Manufacturing & Supply network in Canada.

A Bachelor's degree and 2–5 years in pharma quality management are required, with emphasis on document control and

Qualifications

• Bachelor's degree in a relevant field.
• 2-5 years of experience in quality management systems in the pharmaceutical industry.
• Strong ability to review documents for regulatory compliance and data accuracy.

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

Skills

Document review

Regulatory compliance

Data analysis

Quality systems

Cross-functional collaboration

Education

Bachelor's degree

Tools

Document management system

Job description

Sanofi in Toronto is seeking a Deviation & CAPA Specialist Business System Owner to support the Deviation and CAPA quality system processes at the site, ensuring compliance with global quality and regulatory requirements. The role includes data quality checks, training delivery, risk assessment, and cross-functional collaboration across the Manufacturing & Supply network in Canada.

A Bachelor's degree and 2–5 years in pharma quality management are required, with emphasis on document control and