Reference No. R2771229

Position Title: Quality Control Technical Manager

Department: Biological Testing Support

Location: Toronto, ON

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Manager of Analytical Excellence (AE) is responsible for providing support to ensure the validated state of QC test methods, including a life-cycle management (ALCM) methodology for test method validation assessment, protocol design, coordination of associated laboratory validation activities, analysis of validation data, and the preparation of validation reports. The incumbent will provide support for gap assessments according to regulatory requirements and global guidance for QC test methods. The individual will also manage access to the QC Analytical Excellence laboratory and ensure that cGMP and Quality Systems are maintained in the laboratory area. The manager will have the responsibility to create and update documentations related to validation studies and routine lab management. In addition, the role requires support new equipment/software upgrade and qualification.

• Provide support for assessment of QC test methods for validation needs associated with production process changes including facility, equipment, raw materials and manufacturing processes.
  
• As required, assist with review of historical method validation reports to identify gaps for remediation and assist with preparation of test method validation protocols and reports.
  
• Provide support for assessment of test methods to ensure compliance status to compendial testing requirements.
  

• Review existing SOPs and initiate revision/approval of existing or new SOPs, protocols, reports.
  
• Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.
  
• Manages activities related to Change Control and CAPA, as required.
  
• Responsible for notifying Deputy Director or designates of any non conformances/events.
  
• Leads investigations and provides required support documentation to expedite closure of the deviations.
  

• Coordinating maintenance and re-certification/recalibration of equipment
  
• Assist with equipment commissioning and decommissioning, qualification, and validation.
  
• Following up on instrument alarms and printing charts, as required.
  

• Placing and following up on Facilities word orders in iShift
  
• Training/skills upgrade; complete all assigned training.
  
• Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting department goals; demonstrate progress in preventing or reducing injuries and/or illness
  
• Responsible for ensuring monthly review of logbooks are completed
  
• Responsible for walkthroughs/Gemba in AE lab completion (e.g., monthly GMP walkthrough, quarterly facility walkthrough)
  

• Minimum B.Sc. degree in Immunology, Microbiology, Biochemistry or a related discipline and five (5) or more years of relevant experience.
  

• 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