Validation Manager B100 - Toronto, Canada - Sanofi US

Sanofi US

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reference No. R2675043

Position Title:
Validation Manager B100

Department:
B100 Validation

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 purpose of this position is to manage and ensure validation initiatives supporting B100 start-up, licensure and lifecycle management are performed in accordance with cGxP standards, regulatory and internal requirements.

This purpose is achieved through the management and execution of a project validation master plan, collaboration with a team of cross-functional professionals, and the review and approval of validation protocols, resultant reports and associated documents.

Validation status is maintained through the use of a change control process identifying appropriate revalidation when and where required.

This role is primarily responsible to ensure quality and compliance for all project validation activities across the various project workstreams under CQV, Process Validation, and Cleaning Validation.

Key Responsibilities:

Management of Qualification and Validation

Provide Quality Oversight for qualification and validation of all manufacturing process equipment, single use systems, utilities, facilities, manufacturing processes and associated cleaning, and ITS systems in support of B100 startup, regulatory licensure and lifecycle management. Ensures and verifies compliance to Regulatory and Corporate validation standards and policies. Actively participates, leads, and provides quality leadership on validation strategies. This includes the review and approval validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, reports, validation plans, SOPs, periodic reviews) in accordance with internal and regulatory policies.
Responsible for working with user/system owner to perform validation(s) as per designated validation protocols and to critically evaluate the results to determine if these adequately meet the acceptance criteria. Describe the methods required, provide the acceptance criteria and include a rationale for these choices. Update and revise project, and where applicable, company policy/procedures related to validation as required. Moreover, support the investigation and closure of nonconformances resulting from validation/qualification studies linked to routine revalidations and other validation activities. Also, approve followup on, and close corrective and preventative actions (CAPA) and change controls initiated by the respective project workstreams.

Validation Resource

Provide expertise and guidance with regards to regulatory requirements for validation/qualification activities including quality best practices, validation strategies, procedures, and related activities. Critically evaluate the results to determine if the analysis is valid with sound scientific justification, the outcome adequately meet the acceptance criteria, and the validation is in compliance with the Regulatory and Corporate validation standards and policies.
Responsible for providing Quality Validation responsibility to support the review and approvals of change controls and Nonconformance's. This involves working closely with project key stakeholders, workstream leaders, and support departments to ensure that the appropriate expertise is engaged and that closure timelines are achieved. Support activities to support successful integration of B100 to site.

Collaboration on Local & Global Quality Initiatives

Keeps updated on new rules and industry regulations and ensures alignment of B100 project activities with identified best practices. Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.

Support for External Compliance Activities

Training and Interactions