Manager, Operational Quality - Toronto, Canada - Sanofi US

Sanofi US

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reference No. R2669721

Position Title:
Manager, Operational Quality - FTC

Duration:1 year - contract ends December 2023

Department:
FF&P APU

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

The incumbent is expected to work independently with a high level of autonomy and authority for decision making.

This position requires strong collaboration and communication with key responsible Partners in the APT, and with other stakeholders across the organization, including within Operational Quality & Sterility Assurance, Validation Services, Product Quality, QC and Quality Systems, and MTech.

Key Responsibilities**:

Provides coaching and leadership to shop floor 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 riskbased decision making, required on the shop floor 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 sciencebased, 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 dehydrogenation 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.
Participates in selfinspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections. Identifies and mitigates risks, and leads Shop floor Quality improvement within the APT and more broadly as applicable. Ensures alignment to Global and new Regulatory requirements, participating in gap remediation's, compliance and Site Projects as required.
Scope may be one of the following Operational areas (but not limited to): Formulations, Filling and Packaging (FF&P) and Warehouse at the Toronto Site.
Position liaises across all Industrial Affairs departments, RA, other Sanofi-Pasteur sites (as required).
Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.

Key Requirements:

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 knowledge of cGMPs, compliance trends and vast amount of experience with inspections/audits.
Excellent problem solving (root cause analysis), investigation skills.
Strong influencer and communicator.
Solid experience with continuous improvement methodologies and riskbased approaches.

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