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Validation Manager, B100 - Vaccine

Toronto, Canada

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Responsibilities

Reference No. R2579893

Position Title: Validation Manager, B100 - Vaccine

Department: B100 Validation

Location: Sanofi Pasteur Limited, Toronto, Ontario

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.

Summary of Purpose:

Building 100, a new Vaccine manufacturing facility being constructed at Sanofi’s Toronto site, is an extremely exciting and complex project that will position Sanofi Pasteur on the cutting edge of the digital evolution of biopharmaceutical manufacturing. We are looking for Validation Manager to join this team.

This position is responsible for providing expertise, quality oversight and guidance with regards to regulatory requirements and best practices related to manufacturing process equipment qualification, clean utilities and HVAC qualification.

The candidate will participate in project workstreams, ensure proper execution of validation strategies as well as providing support for the quality processes and procedures. This individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS.

Key Accountabilities:

Management of Qualification and Validation (70%)

  • Provide quality oversight for manufacturing process equipment, CIP, Thermal, Utilities, HVAC qualification activities pertaining to B100 licensure, start-up and lifecycle management.

  • Participates, leads and provides quality oversight on validation strategies.

  • Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.

  • Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.

  • As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.  

  • Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

Support for Internal Compliance Activities (20%)

  • Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices.

  • Provide expertise and guidance with regards to regulatory requirements for manufacturing process systems qualification, as well as quality practices, validation strategies, procedures, and related validation activities.

  • Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.

  • Training Related Activities.

Support for External Compliance Inspection Activities (10%)

  • Responsible for supporting all relevant compliance inspections (e.g. Health Canada, FDA), and customer compliance inspection activities. This includes the responsibility of pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups and the assurance of inspection reports to appropriate management personnel.

  • Represent Quality on key company projects to ensure project deliverables are attained from a validation perspective.  Build and maintain networks within sanofi Pasteur and Sanofi Biologics.

Key Requirements:

Education/Certifications:

  • Bachelor’s Degree in Engineering / Science or related field

  • 7+ years of experience in a GMP controlled environment/pharmaceutical industry is required.

Experience:

  • Excellent understanding of Clean Utility systems (Purified Water, Water for Injection, Clean Compressed Air and Clean Steam), HVAC, CIP and strong validation experience related to the above listed systems

  • Strong experience in Thermal/Sterilization Validation is required.

  • Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, etc.).

  • Understanding of computerized systems validation is required.

  • Technical writing, effective oral and written communication skills, and strong compliance mindset

  • Good understanding of current and evolving regulatory requirements

Competencies:

  • Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS.  Good interpersonal and influencing skills are important for a candidate’s success in this role.

Planning and organizational skills:

  • Ability to anticipate evolutions due to internal and external factors

  • Conflict resolution and problem solving

  • Familiarity with strategic planning, balanced judgment and risk analysis

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.

Sanofi, Empowering Life

#GD-SP   #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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