QA Operations Manager, PCU Lead

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  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.

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.

• 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

• 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.

• Bring the…