Title : Project Quality and Compliance Manager – Contract
Reference No : R2582924
Location : Toronto, Canada
Contract / Employment End Date : 2022-07-15
Sanofi Pasteur: The world’s leading vaccine company
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.
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
This position is responsible for ensuring quality systems required during and subsequent to the B100 project phase are developed, adhered to and sustained for routine commercial operations. This position 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 candidate 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.
Lead and provide Quality oversight for Operational Readiness, Analytical testing and methods, pertaining to B100 licensure, start-up and lifecycle management.
Lead workstreams, influence stakeholders and team members in order to maintain priority for CQV activities during project phase.
Lead streamlining of Analytical test method assessments, validation, stability strategies, and related QC activities required for all project phases.
Review and approve test method validation, test transfer and qualification of reagents protocols and reports, ensuring objectives and timelines are met. Support test method validation by providing direction on validation issues with respect to compliance.
Actively engage in all team responsibilities, including work stream meetings, planning and scheduling meetings, and any related B100 requirements.
Support the Quality Activities for the area of responsibility as follows:
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.
Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
Perform document review, non-conformance investigations, process change requests, support quality improvement, participate on project teams, support self-inspection and promote a strong quality culture and a state of inspection readiness at all times.
Support implementation of the B100 Validation Master Plan, Project Quality Plan and all relevant strategies and validation/Quality plans
Within the B100 SQO organization, provide shop floor knowledge and training to the other Quality Managers and Professionals that have more targeted expertise (e.g., validation or automation).
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 with the Validation Master Plan, Project Quality Plan and adherence to the specific site policies and global policies related to validation and compliance.
A degree in Chemical Engineering, Biology, Biochemistry, or Life Sciences combined with 8 years of relevant work experience within the biopharmaceutical industry. Related to Quality Management and compliance preferably biological industry or equivalent.
In-depth knowledge of biopharmaceutical industry compliance (i.e cGXPs, current industry standards and practices, and process/environmental engineering).
Working knowledge and experience in Test method validation/verification, Stability studies, SAP related QC Planning, sampling and logistics
Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability.
Strong compliance mindset.
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. Good interpersonal and influencing skills are important for a candidate’s success in this role.
Ability to anticipate evolutions due to internal and external factors.
Conflict resolution and problem solving.
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.