Quality Assurance Specialist

Reference no. R2863898

Position title: Quality Assurance Specialist

Department: Quality Assurance, FFIP

Location: Toronto, ON

Fixed Term Contract: 1 year

About the job

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Sanofi Vaccine: The world’s leading vaccine company

Sanofi Vaccine, 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 Quality Assurance Specialist 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 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 Quality Assurance, Validation Services, Product Quality, QC and Quality Systems, and MSAT.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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 risk-based 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 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 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 QA Representative at various committees and boards such as: Change Control Board, Deviation Review Board, +QDCI, FFast, etc.

• Participates in self-inspections, 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) at the Toronto Site.

• Position liaises across all Manufacturing and Supply departments, RA, other Sanofi sites (as required).

• Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.

About you

Key Requirements:

• Bachelor of Science with 3 or more years of relevant experience in pharmaceutical or biological manufacturing environment.

• 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 risk-based approaches.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.

This position is for a new vacant role that is now open for applications.

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyzedata and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identifypatterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,Data Subject Rights Webform. TheData Subject Rights Webform can also be used torequest access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retainhighly talentedemployees from diverse backgrounds, allowing us to benefitfrom a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities requiredduring the recruitment process are available upon request.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

North America Applicants Only

The salary range for this position is:

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA) LINK OR (US) LINK.

La fourchette salariale pour ce poste est la suivante:

La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien