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Manager, Master Data Compliance and System Validation - Job Opportunity at Sanofi

Toronto, Canada
Contract
Mid-level
Posted: August 15, 2025
On-site
CAD 76,200.00–110,066.66 per year

Benefits

Comprehensive extended health care coverage providing enhanced medical benefits beyond standard provincial healthcare
High-quality healthcare programs with prevention and wellness initiatives supporting long-term employee health
Well-crafted rewards package designed to recognize contributions and amplify professional impact
International career mobility opportunities within a global pharmaceutical network
Professional development programs supporting both vertical promotions and lateral career moves

Key Responsibilities

Lead enterprise-wide GMP Master Data quality system development and implementation, directly impacting product safety and regulatory compliance across global manufacturing operations
Review and approve critical GxP Master Data changes that govern manufacturing processes, ensuring pharmaceutical products meet stringent safety and quality standards
Coordinate strategic implementation of new Master Data sets including Bill of Materials and Recipes, enabling efficient manufacturing operations and regulatory adherence
Assess and manage Change Control Requests for GMP Master Data updates, maintaining data integrity that directly affects patient safety and product efficacy
Review and approve system access requests according to regulatory requirements, ensuring data security and compliance with pharmaceutical industry standards
Support comprehensive validation of systems, documentation, and spreadsheets that underpin manufacturing quality assurance processes
Provide technical expertise for regulatory investigations and system upgrades, contributing to continuous improvement of manufacturing capabilities
Establish and monitor Key Performance Indicators to ensure data quality excellence and drive measurable process improvements across manufacturing operations

Requirements

Education

Bachelor's degree

Experience

3-5 years of experience

Required Skills

Knowledge of cGMP regulations and current industry standards Working experience on Material Management Module Understanding of quality management systems and regulatory compliance trends Strong analytical and problem-solving skills Excellent communication and teamwork abilities Experience with project management in a fast-paced environment Basic understanding of biopharmaceutical processes (e.g., fermentation, cell culture, formulation) Experience with data analysis and experimental design Knowledge of change control and validation processes in GMP environments
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented digital transformation with increased focus on data integrity and master data management systems. Companies are investing heavily in automated compliance solutions and real-time data validation platforms to meet evolving regulatory requirements from FDA, Health Canada, and EMA. This trend is driving demand for professionals who can bridge the gap between traditional GMP compliance and modern digital manufacturing systems. Regulatory agencies are implementing stricter data governance requirements, particularly following recent FDA guidance on data integrity and computerized systems validation. This has created a surge in demand for specialists who understand both regulatory frameworks and technical system implementations. The industry is moving toward risk-based approaches to data management, requiring professionals who can assess and prioritize compliance activities based on patient safety impact. Biopharmaceutical manufacturing is increasingly adopting Industry 4.0 technologies, including advanced analytics, artificial intelligence, and integrated manufacturing execution systems. This technological evolution requires master data professionals who can ensure compliance while enabling digital transformation initiatives. The convergence of traditional quality assurance practices with modern data science approaches is creating new career opportunities in this specialized field.

Salary Evaluation

The provided salary range of CAD 76,200-110,066 appears competitive for the Toronto pharmaceutical market, considering this is an 18-month contract position. For permanent roles, similar positions typically command CAD 85,000-125,000 annually, so the contract rate includes appropriate premium compensation. The range reflects the specialized nature of GMP compliance expertise and Sanofi's position as a tier-one pharmaceutical company.

Role Significance

Typically manages or coordinates with cross-functional teams of 5-15 professionals including data analysts, validation specialists, quality assurance personnel, and IT system administrators across multiple manufacturing sites.
This manager-level position represents a mid-to-senior professional role with significant regulatory and operational impact. The incumbent serves as a subject matter expert responsible for enterprise-wide data governance decisions that directly affect product quality and patient safety. The role combines technical expertise with strategic oversight, positioning the professional as a key decision-maker in manufacturing operations.

Key Projects

Implementation of new manufacturing execution systems requiring comprehensive master data validation and regulatory compliance assessment Global harmonization of master data standards across multiple manufacturing facilities to ensure consistent product quality and regulatory adherence Regulatory remediation projects addressing FDA or Health Canada observations related to data integrity and system validation Digital transformation initiatives integrating advanced analytics and automated quality control systems while maintaining GMP compliance Cross-functional validation projects for new product launches requiring establishment of complete master data frameworks

Success Factors

Deep understanding of pharmaceutical regulatory landscape combined with practical experience in manufacturing operations enables effective translation of compliance requirements into operational procedures. Success requires staying current with evolving FDA, Health Canada, and ICH guidelines while maintaining practical focus on manufacturing efficiency. Strong analytical and project management capabilities are essential for managing complex validation projects with multiple stakeholders across quality, manufacturing, IT, and regulatory functions. The ability to prioritize competing demands while maintaining regulatory compliance timelines is critical. Excellent communication skills enable effective collaboration with diverse technical and non-technical stakeholders, from manufacturing technicians to senior executives. Success requires ability to explain complex regulatory requirements in practical terms that drive appropriate organizational action. Technical proficiency in manufacturing execution systems, particularly Material Management modules, combined with understanding of biopharmaceutical processes enables effective evaluation of system configurations against regulatory requirements. Change management expertise facilitates successful implementation of new processes and systems while maintaining business continuity and regulatory compliance throughout transition periods.

Market Demand

High demand driven by regulatory complexity, digital transformation initiatives, and the critical nature of pharmaceutical data integrity in patient safety.

Important Skills

Critical Skills

GMP regulations knowledge forms the foundation for all compliance decisions and risk assessments, directly impacting patient safety and regulatory approval status. This expertise enables evaluation of data changes against regulatory requirements and ensures manufacturing operations maintain compliance with evolving regulatory standards. Material Management Module experience provides essential technical foundation for understanding how master data flows through manufacturing execution systems and impacts production operations. This knowledge enables effective evaluation of system configurations and data integrity controls. Change control and validation process expertise ensures all system and data modifications follow appropriate regulatory protocols while maintaining operational efficiency. This skill set is critical for managing the complex approval processes required in pharmaceutical manufacturing environments.

Beneficial Skills

Advanced data analysis and experimental design capabilities enable more sophisticated approach to data quality assessment and process improvement initiatives, supporting continuous improvement objectives while maintaining regulatory compliance Project management certification or advanced training enhances ability to coordinate complex cross-functional initiatives and manage multiple stakeholder requirements while meeting regulatory timeline commitments Business process optimization knowledge enables identification of efficiency opportunities while maintaining compliance requirements, supporting both operational excellence and cost management objectives

Unique Aspects

This 18-month contract position offers unique opportunity to contribute to major system implementation or regulatory remediation initiative at a global pharmaceutical leader, providing intensive experience that typically spans several years in permanent roles
The role combines strategic master data governance with hands-on technical validation work, offering comprehensive exposure to both regulatory compliance strategy and operational implementation across manufacturing operations
Position provides direct exposure to global pharmaceutical regulatory requirements and industry best practices, with opportunity to influence enterprise-wide data governance standards that impact patient safety and product quality
The Toronto location offers unique perspective on both North American regulatory requirements and Sanofi's global manufacturing network, providing valuable international pharmaceutical industry experience

Career Growth

Typically 3-5 years to progress to senior management positions, with progression timeline dependent on demonstration of leadership capabilities, successful project delivery, and expansion of regulatory expertise across broader therapeutic areas and geographic regions.

Potential Next Roles

Senior Manager or Director of Quality Systems with expanded responsibility for global quality management systems and regulatory strategy across multiple therapeutic areas and manufacturing facilities Regulatory Affairs leadership positions focusing on CMC (Chemistry, Manufacturing, and Controls) submissions and regulatory compliance strategy for new product development and commercial manufacturing Manufacturing excellence or operations leadership roles leveraging deep understanding of quality systems and regulatory requirements to drive operational efficiency and continuous improvement Consulting positions with specialized pharmaceutical consulting firms serving as subject matter expert for regulatory compliance and quality systems implementations across multiple pharmaceutical companies

Company Overview

Sanofi

Sanofi stands as one of the world's largest pharmaceutical companies with global operations spanning over 100 countries and a diverse portfolio covering prescription medicines, vaccines, and consumer healthcare products. The company has established itself as a leader in multiple therapeutic areas including diabetes, immunology, oncology, and rare diseases, with a robust pipeline of innovative therapies in development.

Sanofi maintains a top-five global pharmaceutical company position with annual revenues exceeding €40 billion and a strong presence in both developed and emerging markets. The company's diversified portfolio and geographic reach provide stability and growth opportunities, while significant R&D investments position it competitively for future market expansion.
Sanofi's Canadian operations represent a significant regional hub with manufacturing facilities, research centers, and commercial operations supporting both domestic market needs and global supply chain requirements. The Toronto location provides access to Canada's largest pharmaceutical market while leveraging the country's favorable regulatory environment and skilled workforce.
Sanofi emphasizes scientific excellence and patient-focused innovation while maintaining strong commitment to diversity, inclusion, and professional development. The company culture balances global pharmaceutical industry standards with local market adaptation, providing employees with international career opportunities and exposure to cutting-edge pharmaceutical development and manufacturing practices.
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