Sanofi Group Manager R&D QA Validation in Toronto, Ontario

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.

Job Overview

The purpose of this position is to ensure that all validation initiatives involving computer, equipment, utility, testing and business function-systems that support Research and Development are in compliance with Regulatory and Global Quality policies and standards. This is achieved through management and execution of a site validation master plan, participating in the assessment and evaluation of various equipment, off-the-shelf and/or customized software application packages, selection of specific firmware, vendors’ quality audits, ensuring 21CFR Part 11 compliance. The incumbent will provide technical quality support to various user groups including Information System, purchasing and EIT is a key aspect to ensure the right computerized systems are purchased and GMP compliances are met. Collaboration with the various groups is essential to the success of achieving and maintaining validation status.

Key Responsibilities

  • Provide quality support to the evaluation of software applications and firmware associated with computerized systems and equipment used in laboratories, clinical manufacturing and facilities/utilities.

  • Provide technical support to the design and system configuration including coding and macros, network interface and PID.

  • Provide final review and approval of all computer/non computer validations design and execution.

  • Advise on test requirements, scope, and acceptance criteria as per project deliverables.

  • Ensure that the methodology used in qualification testing will thoroughly test and challenge.

  • Review and approve development documentation for GMP compliance, business risk, and consistency.

  • Provide and monitor non-conformance results during the validation studies to determine acceptable remediation/corrective actions.

  • Coordinate with user/system owner to perform validation as per the designated validation protocol.

  • Provide subject matter expertise during External and Internal Regulatory Inspections defending the programs and the individual validated equipment/systems and providing timely and technically completed responses to audit observations.

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

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

  • Participate in local customer service initiatives including those focusing on improving R&D QA support.

  • Develop and maintain site policies and procedures that describe validation initiatives that are aligned to regulatory requirements and global Quality and Industry standards. Update and/or provide training to users on validation policies and procedures.

  • Develop documentation for specifications, protocols, plans, training material and SOPs for systems including stand alone and custom built systems (ie. Automated systems, Analytical tests equipment including macros for calculations methods).

  • Provide professional and technical support during corporate and external regulatory inspections in a competent and convincing manner.

  • Ensure all required documentation is provided by vendor/consultant.

Required Qualifications

  • Bachelor of Science or equivalent in Computer and/or Engineering Sciences

  • Degree in MBA and certifications in Project Management and/or Six Sigma, an asset

  • Formal training in computerized system validation, GAMP, and CFR 21 part 11 is an asset

  • Five to seven years related job experience required

  • Experience of manufacturing environments (equipment/facilities/utilities) for biologics

  • Experience/knowledge in validation design/approach and System Development Life Cycle (SDLC)

  • Good knowledge of Quality Systems/Practices

  • Practical knowledge of vaccine manufacturing

  • Ability to evaluate Vendors’ Software Applications and Firmware

  • Experience on programming of PLC software and PID control loops

  • Excellent problem solving and report writing

  • Good communication skills based on global interaction

  • Ability to read/write French is a plus

  • Available for approximately 10 - 15 % travelling

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.

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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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life