Production Compliance Manager

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City : Toronto

Category : Production, Biologics

Industry : Pharmaceutical

Employer : Sanofi

Production Compliance Manager

About Sanofi Pasteur

Sanofi Pasteur, 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 Production Compliance Manager is a detail oriented and results driven individual with a strong understanding of biologics manufacturing, cGMP, root cause analysis and possesses exceptional technical writing skills.

The Production Compliance Manager will be responsible for leading deviation Investigations, ensuring Manufacturing Shop Floor compliance and execution of continuous improvement initiatives.


KEY ACCOUNTABILITIES
Responsible for all critical, major and minor deviations associated with the Platform:

  •  Lead and determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the manufacturing shop floor.
  • Perform Root Cause Analysis by conducting Shop Floor Production Walk-throughs (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.
  • Identify expertise required for the investigation (MTech, Technical Services, QC, QOVS, QOSA).
  • Participate in Autonomous Production Team (APT) support team meetings for planning and execution of investigations.
  • Prepare manufacturing investigations and provide guidance on reports prepared by technical staff. 
  • Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise and comprehensive.
  • Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines. 


Develop appropriate corrective and preventive actions:

  • In collaboration with platform management and other stakeholders, initiate/develop appropriate CAPA in QS with a clearly defined scope to address the root cause.
  • Review CAPA associated with recurring issues and escalate any issues to Platform Leaders.
  • Work with Platform Leaders to identify and develop process improvements to remediate risks. 

Continuous Improvement and GMP Documentation Review within the Platform:

  • Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Manufacturing Shop Floor operations.
  • Participate in special projects for production process improvement projects to meet GMP requirements and address inspection observations.


PHYSICAL WORKING CONDITIONS

  • Vaccine Manufacturing Shop Floor (Production) area environment


REQUIREMENTS
•    Minimum Bachelors of Science or Engineering (Preferred MSc. in Microbiology, Biochemistry, Engineering, Biotechnology)
•    Minimum of four (4) years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, or Quality Operations
•    High level of knowledge of GMP in pharmaceuticals/biological manufacturing environment
•    Experience in regulatory inspections
•    Must possess excellent communication and organization skills.
•    Six-sigma or other root cause training/certifications and experience.

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

 #GD-SP          

 #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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