Reference No. R2739966

Position Title: Manager, Quality & Operational Readiness – Vaccines

Duration: Fixed-Term - Contract End Date: November 8, 2024

Department: B100 Operational Readiness

Location: Toronto, Ontario

Sanofi Vaccines

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.

Position Summary:

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. 

Key Responsibilities:

• 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.

• Along with operations, identify gaps and provide recommendations on improvement.

• 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.

• Understand and work to maintain adherence to SQO budget.

• 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.

Scope and dimensions:

• Breadth of responsibility (global/regional/country/site): Site

• Key dimensions: Project success, Shop floor quality/compliance adherence, Sterility Assurance, Validation.

• Freedom to act, level of autonomy: Position has a high degree of autonomy in his area and is expected to make decisions and interpretations within broadly defined requirements.

Key Requirements:

• Bachelor’s degree, with a scientific discipline, and 5 or more years of relevant experience in pharmaceutical or biological manufacturing.

• Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically,

• Commit to Customers, Develop People, Make Decisions, Lead Teams

• Key technical competencies and soft skills: Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability.

Pursue Progress

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

#GD-SP #LI-SP

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!