Quality Assurance Specialist

Sanofi; Toronto; On-site; CAD 70,000 - 100,000; Full time

Job summary

Sanofi in Toronto, ON is seeking a Quality Assurance Specialist to uphold GMP compliance and support product quality throughout lifecycle.

You will lead audits, investigate deviations, and collaborate with production to drive continuous improvement, risk management, and regulatory readiness.

Candidates should have a Bachelor's in a scientific field and at least two years in pharma QA.

Qualifications

• Bachelor's degree or higher in Pharmacy, Chemistry, Biochemistry, Life Sciences, Chemical Engineering, or related field.
• Minimum 2 years of pharmaceutical quality assurance or operations experience.
• Strong knowledge of cGMP and regulatory requirements.
• Experience with quality documentation and change control processes.

Responsibilities

• Ensure activities comply with regulatory requirements and GMP.
• Audit production processes and address quality issues.
• Collaborate with production to maintain quality across product lifecycle.
• Lead root cause analyses and preventive actions.
• Support internal and external audits and regulatory inspections.

Skills

GMP compliance

QA documentation

Root cause analysis

Change control

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or Life Sciences

Job description

Reference no. R2871503

Position title: Quality Assurance Specialist

Department: QA DS B89/90

Location: Toronto, ON

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.

Our Team/ 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

Section 3: Key Involvement in Decision-Making Process

Key Roles (D,A,I)

• 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)

Section 4: Local specificities

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

Education / Experience Requirements:

• Bachelor's degree or higher preferably in Pharmacy, Chemistry, Biochemistry, Life Sciences, Chemical Engineering, or a related scientific field
• Minimum 2 years of experience in pharmaceutical quality assurance or operations (depending on level)

Technical Skills:

• Demonstrated experience in Drug Substance / Drug Product (DP) quality operations
• Working knowledge of cGMP and GxP regulations in a regulated pharmaceutical environment
• Experience with quality documentation, compliance activities, and regulatory requirements
• Familiarity with change control processes and quality systems
• Background in process improvement and quality investigations
• Quality Assurance and Change Control Processes
• Inspection Readiness
• Root Cause Analysis / RCA / Preventive Action
• Regulatory Requirements
• QA Standards
• Documentation Review
• Manufacturing Processes
• Product Quality Assurance
• Risk Management
• Cross-Team Communication and Collaboration
• Stakeholder Management

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.

AI Usage

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 datasubject 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

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.