Manager, Quality & Operational Readiness – Vaccines page is loaded Manager, Quality & Operational Readiness – Vaccines Apply locations Toronto, ON time type Full time posted on Posted 4 Days Ago job requisition id R2739966 Reference No. Position Title: Manager, Quality & Operational Readiness – Vaccines Fixed-Term - Contract End Date: November 8, 2024 Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. The Manager – Quality & Operational Readiness is responsible for ensuring all quality related activities for the B100 project phase are developed, managed, followed and sustained for eventual routine manufacturing operations. The incumbent is expected to provide direction and guidance for quality related issues encountered as part of the overall project. Additionally, liaising between the project team and routine site quality operations will be required as part of the role. During the qualification phase of the project the incumbent will be responsible for ensuring all operational readiness activities are completed for the facility. All activities relating to quality systems integration, oversight of deviations, CAPAs, change controls, training, documentation, vendor audits etc. will be managed by the incumbent. In line with the B100 project, the incumbent will 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. The Manager – Quality & Operational Readiness is expected to work independently and with a level of autonomy and authority in decision-making to ensure all quality related activities are in compliance against regulatory and compendial requirements. In parallel, the role is also responsible for ensuring overall schedule adherence and alignment with approved project direction. Responsible for managing the operational quality requirements for a processing area. Provide oversight of deviations, CAPAs and change controls. Review and approve training curriculums, SOPs and project procedures. In line with the B100 project, identify process improvement opportunities within the SQO area. Support overall project quality related activities (specific to electronic batch record system) such as: SIT, FS, UAT approvals. From identification to resolution and correction, be involved with deviations associated with test method verification/validation. Support engineering phase runs by providing quality oversight. Identify site CAPAs implemented (i.e., regulatory) that impact future B100 operations and develop path forward in conjunction with the project team. Escalate quality concerns to senior management in a timely manner. Actively engage in all team responsibilities, including work stream meetings, planning and scheduling meetings, and any related B100 requirements. Breadth of responsibility (global/regional/country/site): Site Project success, Shop floor quality/compliance adherence, Sterility Assurance, Validation. Bachelor's degree, with a scientific discipline, and 5 or more years of relevant experience in pharmaceutical or biological manufacturing. Key technical competencies and soft skills: Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.Sanofi is an equal opportunity employer committed to diversity and inclusion. Accommodations for persons with disabilities required during the recruitment process are available upon request. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: #Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.Manager, Operational Quality – Vaccines locations Toronto, ON time type Full time posted on Posted 7 Days Ago Production Compliance Manager - Vaccines locations Toronto, ON time type Full time posted on Posted 30+ Days Ago Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. As an organization, we change the practice of medicine; Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. #