Manager, Master Data Compliance and System Validation

R2815798 Manager, Master Data Compliance and System Validations

Duration: 18 months

Location: Toronto, On

About the Job

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.

The Position is responsible for the establishment and maintenance of GMP Master Data standards, policies and procedures to improve data quality and ensure compliance. The incumbent will be required to interpret regulatory requirements, site policies and best practices in order to support the following:

• Define compliance requirements in the roll-out of new GMP Master Data sets (e.g., Bill of Materials, Recipes, etc). Review, assess and, when appropriate, approve changes to GMP Master Data, which governs and / or supports GMP processes whose failure would have an impact on Product Quality, Safety or violation of a GMP Requirements.

• Review and approve system access requests to applicable GMP applications.

• Support System assessments, investigations and system upgrades. Support integration between business process requirements and system functionalities, configuration and master data.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Lead GMP Master Data quality system development, implementation, and maintenance

• Review and approve GxP Master Data changes while ensuring regulatory compliance

• Coordinate implementation of new Master Data sets and define quality requirements

• Assess and manage Change Control Requests for GMP Master Data updates

• Review and approve system access requests according to regulatory requirements

• Support validation of systems, documentation, and spreadsheets

• Provide technical expertise for investigations and system upgrades

• Establish and monitor KPIs to ensure data quality and process improvement

About You

• Bachelor's degree with 3-5 years of experience is required.

• 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)

• Preferred: Experience with data analysis and experimental design Knowledge of change control and validation processes in GMP environments

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 current vacant role that we are actively hiring for.

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.

#GD-SP
#LI-SP

#LI-Onsite

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.

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.