Quality Assurance specialist - Vaccines at Sanofi Aventis US LLC

Toronto, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

17 Apr, 26

Salary

110066.0

Posted On

17 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Good Manufacturing Practices, Regulatory Compliance, Auditing, Problem Solving, Communication, Decision Making, Risk Management, Continuous Improvement, Collaboration, Data Analysis, Root Cause Analysis, Quality Metrics, Quality Standards, Patient Safety, Product Excellence

Industry

Pharmaceutical Manufacturing

Description

R2837144 Quality Assurance specialist - Vaccines Location: Toronto, ON Duration: Fixed Term, Dec 2026 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. Overview: The Quality Assurance team serves as a critical guardian of patient safety and product excellence through rigorous GMP record review and batch release activities, while fostering a culture of quality ownership and continuous improvement across operations. Through systematic oversight and shopfloor expertise, we proactively identify and mitigate quality risks, maintain robust quality systems, and ensure full regulatory compliance. Our collaborative partnerships across all functions embed quality principles into every aspect of operations, enabling the timely delivery of high-quality products to patients while upholding the highest standards of operational excellence. 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: Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations Conducting regular audits of production processes to identify and address potential quality issues Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor Managing and resolving quality-related issues in a timely and effective manner Monitoring and analyzing quality performance metrics, implementing corrective actions as needed Leading root cause analysis investigations for quality incidents and implementing preventive measures Participating in internal and external audits and regulatory inspections providing support and documentation Developing and implementing risk management strategies to mitigate potential quality issues Fostering a culture of quality and continuous improvement across the organization Key Roles: Request corrections when GMP rules are not respected (D) Prioritize quality and compliance objectives (A) Proactively implement remediation action from findings from internal and external audits related to quality issues (D) Request quality improvement initiatives and strategies (D) Identify discrepancies and corrective/preventive actions that need to be taken (D) Escalate to upper management any failure in GMP execution on shopfloor (I) Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I) Advise on how to present a topic and answer specific questions (A) Advise on risk management strategies and plans (A) Advise on initiatives to promote a quality-focused culture (A) Additional Accountabilities: Provide QA support to any required APU or PCU on site as designated by the QA Ops Manager & PCU Lead Any other duties that may arise as required About You: Bachelor's degree in science or engineering with 3-5 years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility. Master's degree with 2+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility. Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically. Strong decision making skills. Excellent communication and influencing skills. Good understanding of GxPs, regulatory and compliance trends. Problem solving skills. 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. Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, 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 regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request 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 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. #GD-SP #LI-SP #LI-Onsite 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: $76,200.00 - $110,066.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. La fourchette salariale pour ce poste est la suivante: $76,200.00 - $110,066.66 Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien. Global Terms & Conditions and Data Privacy Statement 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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Quality Assurance specialist ensures compliance with regulatory requirements and Good Manufacturing Practices while conducting audits and collaborating with production teams. They also manage quality-related issues and lead investigations into quality incidents.