Reference Number:R2872450

Position title: QA Operations Manager, PCU Lead

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.

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:

1. Quality Assurance Management:

- Develop and implement annual quality assurance objectives for E&M;/Distribution manufacturing, aligning with organizational strategy and vision.
- Ensure compliance with GMP, regulatory requirements, and company quality standards for all E&M;/Distribution production activities.
- Maintain a system to identify, track, and mitigate quality risks in E&M;/Distribution manufacturing.
- Oversee batch release processes, including release of batches for further manufacturing and ensuring timely and compliant final disposition of completed batches.
- Lead investigations into quality issues, deviations, and out-of-specification results related to E&M;/Distribution.
- Support other duties as required.

2. Process-Centric Unit Management:

- Collaborate closely with production teams to maintain quality standards throughout the E&M;/Distribution ecosystem.




- Conduct regular audits of E&M;/Distribution processes to identify and address potential quality issues.
- Oversee all investigations related to E&M;/Distribution production to ensure proper risk assessment and product impact evaluation.
- Manage and resolve quality-related issues in E&M;/Distribution in a timely and effective manner.

3. Quality Systems and Continuous Improvement:

- Establish and monitor key performance indicators (KPIs) for E&M;/Distribution quality assurance activities.
- Identify and drive continuous improvement initiatives to enhance quality and operational efficiency in E&M;/Distribution production.
- Promote a culture of quality throughout the E&M;/Distribution organization.
- Evaluate and recommend new technologies, tools, and methods to enhance E&M;/Distribution quality assurance processes.

4. Team Leadership and Development:

- Lead and manage the E&M;/Distribution quality assurance team, including hiring, training, coaching, and performance evaluation.
- Ensure the team is properly qualified and trained on current GMP requirements and quality standards.

5. Regulatory Compliance and Inspections:

- Participate in regulatory inspections and audits, providing expertise on E&M;/Distribution quality assurance.
- Ensure the site maintains valid manufacturing licenses and product permissions for E&M;/Distribution.

About You

Education and Experience:





- Minimum Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field; advanced degree preferred.
- Minimum of 8 years of experience in quality roles; pharmaceutical industry preferred
- Preferred experience/ in-depth knowledge of GMP regulations and guidelines.
- Prefer candidate with previous management experience

Skills & Qualifications:

- Strong understanding of pharmaceutical manufacturing processes and associated quality control methods.
- Excellent analytical and problem-solving skills, with the ability to make data-driven decisions.
- Proven leadership experience in leading and coaching teams, fostering growth and innovation.
- Effective communicator with strong interpersonal skills.
- Interacts effectively with stakeholders, including cross-functional teams and manufacturing operations.

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 recent vacant role that is now open for applications.

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learn

📌 QA Operations Manager, PCU Lead (Toronto)
🏢 Sanofi
📍 Toronto