Manager - Quality & Operational Readiness - Toronto, Canada - Sanofi US

Sanofi US

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reference No. R2675012

Position Title:
Manager - Quality & Operational Readiness - Vaccine

Department:
B100 Operational Readiness

Location:
Toronto

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.

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.
Competencies (LEAD model) key competencies the job holder will be evaluated on.
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._

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