Join the Sanofi Family building our future; this role will support B100 (Building 100) our new 150,000-square-foot Bulk Biologics Facility where we will manufacture acellular component Pertussis (5-acP), Tetanus and Diptheria.
The Project Quality and Compliance Manager is responsible for providing expertise, quality oversight and guidance with regards to regulatory requirements and best practices for Drug Substance and/or Drug Product Vaccine manufacturing. The Project Quality and Compliance Manager will be an integral part of the B100 project and lead/participate in project workstreams, ensure proper execution of qualification/validation strategies as well as providing support for the quality processes and procedures. This position will also liaise with global and external partners to ensure the successful start-up of the B100 facility. Thorough review and approval of quality processes and documentation in accordance with internal and regulatory policies will be required throughout the project lifecycle.
Management of Qualification/ Quality Systems
- Lead and provide quality oversight for Project Quality Risk management, audit readiness, and operational readiness activities pertaining to B100 licensure, start-up and lifecycle management.
- Provide audit expertise and coordinate activities with regards to preparation of internal/external audits, global audits and PAI readiness by coordinating activities with required stakeholders. Provide expertise and coordinate activities with regards to supplier quality agreements.
- Lead and coordinate activities with routine manufacturing site and B100 core teams for operational readiness activities pertaining to integration of B100 with site procedures, systems, programs and training required for commercial operations.
- Create and maintain the project risk management database. Lead review meetings, communication and creation of reports to support gate reviews for the project. Provide strategic direction to ensure quality requirements are met during operational readiness activities.
- Lead and create training modules for Quality group for routine operations by liaising with site L&D and B100 core teams.
- Review, assessment and approvals of change controls, deviations and CAPAs as required.
- Represent Quality on key project workstream to endure project deliverables are attained from a quality perspective.
- As required, represent Quality Operations on B100 project teams and/or sub-teams and/or project working groups to provide direction on validation issues with respect to quality and compliance.
- Keeps updated on new rules and industry regulations, and define and align internal quality systems with best practices.
- Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.
- Influence stakeholders and team members in order to maintain priority for quality projects. Support to develop and deliver high quality documentation within limited timeframes in order to align with current regulatory requirements and project commitments defined for B100.
- The Quality Manager is expected to work independently and with a level of autonomy and authority in decision-making as a delegate to the Deputy Director as necessary to ensure on-going alignment to the specific project policies and global policies.
- The incumbent is expected to provide guidance (or research issues if no guidance is readily available) for quality- or compliance-impacting decisions in the development and implementation of documents and records.
- This role will be part of the B100 Quality team at Sanofi Pasteur Toronto and will support project Quality, Compliance, Audit and Training aspects. The role is an exciting opportunity with B100 start-up facility project and requires understanding of the complexity in facility/automation/process design/qualification, and effective cross-functional interaction.
- Minimum Bachelors Degree in Engineering / Science combined with 8 years of relevant working experience within the pharma/biopharmaceutical industry related to qualification or quality systems.
- Working knowledge and hands-on experience with qualification activities, supplier quality and quality system management.
- Technical writing, effective oral and written communication skills, and mature quality and compliance mindset.
- Good understanding and working knowledge of current and evolving regulatory requirements.
- Working knowledge of vaccine processes and manufacturing requirements is an asset.
- Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk-manufacturing, Manufacturing Technology, Engineering, and QC Labs. Good interpersonal and influencing skills are important for a candidate’s success in this role.
- Familiarity with strategic planning, balanced judgment and risk analysis.
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.
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.