Manager, Master Data Compliance and Validation
Reference #: R2500804
Department: Quality Systems Validation
Location: Toronto, Ontario
About Sanofi Pasteur
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
The position is responsible for the establishment and maintenance of GMP Master Data standards, policies and procedures to improve data quality and compliance and support cross-functional validation activities. The incumbent will be required to interpret regulatory requirements, site policies and best practices in order to:
- Define precise 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 Master Data. A Master Data set is a logical grouping of related Master Data elements which together form a category.
- Review and approve system access requests to key GMP applications
- Quality System assessments, investigations and upgrades. Support integration between business process requirements and system functionality, configuration and master data.
- Support validation activities, assessments and processes across multiple validation disciplines as required.
Develop, implement and support a Quality System for the management of GMP Master Data, to ensure regulatory compliance
- Author required Quality System Policies and Procedures to ensure appropriate procedures are in place.
- Establish and maintain KPIs to ensure productivity and quality are consistently met and if required implement improvement activities
- Deliver training on the Master Data compliance process and related Policies and SOPs
Review and approve GMP Master Data and Access Requests
- Interpret rules, regulations and site policies related to Master Data creation and updates in order to provide precise and concrete guidance on requirements for compliance (e.g., such as requirements in support of implementation of Bar Coding/MQSI)
- Identify source data, and when required, collect applicable GMP data to support updates to Master Data (source data (official/approved data) such as those defined in Material Master Specifications)
- Review and approve changes to Master Data
- Review and approve system access requests for compliance with site policies and regulatory requirements (e.g. Training)
- Review and where specified, the approvals of SOP’s, User, Design and Functional Specifications, drawings and validation documentation as required.
Coordinate roll-out and implementation of new Master Data sets
- Define specific requirements for quality and compliance as new Master Data sets are planned for implementation (i.e., Master Data sets such as Bill of Materials, Recipes, etc)
- Liaise with impacted Master Data owners and source documentation to ensure compliant roll-out of new Master Data sets
Assess Change Control Requests
- Assess Change Control Requests for proposed updates to GMP Master Data
- Identify required activities to implement Change Requests
- As required, execute and complete Change Control Action Items
Quality Systems Support
- Support investigations, technical and procedural issues related to systems of expertise
- Provide supportive role in changes and upgrades to existing systems of expertise
- Support implementation of validated spreadsheets used for GMP related operations
- Ensure that methodology used to test and challenge the equipment/systems are in place and are suitable.
Education & Experience:
- Minimum Bachelor of Science (preferred Biology/Microbiology/Chemistry) or Bachelor in a related field (Applied Sciences, Engineering)
- Min four (4) years’ experience and understanding of manufacturing/testing environments in the pharmaceutical Biotech Industry
- Working knowledge on Master Data management principles and core Master Data elements in systems such as SAP.
- Working knowledge of facility, utility, sterilization and computerized system validation/CSV principles, practices and regulatory requirements.
- Knowledge and competencies in project management principles
- Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage in an efficient and practical manner.
- Flexibility to plan and work with rapidly changing business needs and ability to accommodate as a subject matter expert.
- Good knowledge of license activities and management of license maintenance
- Good problem solving skills
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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.