Manager de Projet Data - Toronto, ON, Canada - EightSix Network Inc

Description

Position Title:
Manager, Operational Quality – Vaccines
Fixed-Term - Contract End Date: December 31, 2025

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 Operational Quality Manager provides quality oversight and guidance to the designated Autonomous Production team (APT) or area of responsibility, on all aspects of Shopfloor / operational activities.

The incumbent is accountable for quality and compliance of licensed products, in alignment with Sanofi Pasteur Quality Standards, Quality Systems, and current Good Manufacturing Practices.

This position requires strong collaboration and communication with key responsible Partners in the APT, and with other stakeholders across the organization, including within OQ-SA, Validation Services, Product Quality, QC and Quality Systems, MTech and ETS.

Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture.

Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.

Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.

Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.

Participates as QO Representative at various committees and boards such as: Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc.

Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable.
Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required.

Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.

Scope may be one of the following Operational areas (but not limited to): cP, DTPPD/ Adsorption, Formulations, Filling and Packaging (FF&P), QC, Technical Services at the Toronto Site

Bachelor of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.

Experience interacting with regulatory agencies and health authority inspections is required.
Strong leadership and management capability
Excellent problem solving (root cause analysis), investigation skills
Solid experience with continuous improvement methodologies and risk-based approaches
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.
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