Reference No. R2767851

Position Title: Compliance Manager- Vaccines

Department: B200 Operations - Downstream

Location: Toronto, Ontario

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. Your job, as a Production Compliance Manager within our global vaccines business will be to drive continuous improvement in Influenza drug substance manufacturing by leading deviation investigations and using your findings to deliver positive change.

• Focusing on the Downstream operations (Eggs receiving, Inoculation, Incubation and Harvest), 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 shop floor.
  
• Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs.
  
• Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect, and analyze data to determine the true root cause.
  

• Review and provide guidance on reports prepared by technical staff.
  
• Prepare manufacturing investigations to support other functional areas as requested.
  
• Write and manage associated documentation, actions and timelines.
  
• 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.
  
• Ensure actions are assigned to the appropriate individuals and completed to meet timelines.
  

• Support investigation of non-conformances during project phase, identify root cause, and work with the team to identify and implement appropriate corrective actions.
  
• Support shop-floor execution of Engineering/Development/Process Performance Qualification (PPQ) and Environmental Monitoring Process Qualification (EMPQ) protocols, as needed.
  

• Initiate and manage change control requests affecting the B200 Flu Manufacturing department.
  
• Collaborate with assessors for evaluation of changes.
  
• Ensure timely closure of change controls.
  
• Track and monitor change control progress.
  

• In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause.
  
• Initiate CAPAs in the Quality System as required.
  
• Support manufacturing staff on updating GMP documents arising from CAPAs.
  
• Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders.
  
• Work with Platform Leaders to identify and develop process improvements to remediate risks.
  

• Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.
  
• Utilize the Deviation Review Board Governance as required.
  
• Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable.
  
• Present and defend investigations and provide support to the area manager for process / procedure topics during Regulatory inspections and other audits.
  

• Lead and manage Data Integrity activities, initiatives, and continuous improvements within the Platform in collaboration with APT Support teams and QOVS.
  
• Perform Shop Floor Production Walkthroughs (GEMBA) to identify compliance gaps.
  
• Track and develop action plan to address gaps, as required.
  
• Act as Administrator for standalone equipment and ensure compliance with regular user access reviews, as well as audit trail backup and storage.
  

• Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Shop Floor operations.
  
• Participate in special projects for production process improvements to meet GMP requirements and/or address inspection observations.
  
• Provides metrics and other reports as required.
  
• Support GMP Documentation review (eBPRs, logbooks, etc.) as required.
  

• Minimum B.Sc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science
  
• A minimum of two (2) years (four years preferred) of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role
  
• High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
  
• Experience in regulatory inspections an asset
  
• Good problem-solving skills
  
• Must possess excellent communication, technical writing, and organization skills.
  
• Six-sigma or other root cause training and experience an asset
  
• Knowledge and experience with multiple software programs such as Word, Outlook, Visio, and PowerPoint
  

• 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
  

• Join one of the largest vaccine manufacturers in the world in our quest to ensure no one dies of a vaccine-preventable disease
  

• Sanofi Toronto is the site of some of Canada's largest investments in life sciences
  

• Sanofi Toronto is rated as one of the GTA's top employers
  

• Take advantage of a once in a lifetime opportunity to be a part of the qualification and start-up of a brand-new, state-of-the-art vaccine manufacturing facility