Reference No. R2771277

Position Title: Sterility Assurance Technical Manager, Vaccines

Department: B100 Quality

Duration: Fixed Term Contract End Date: November 30, 2026

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.

The Sterility Assurance Technical Manager, B100 is responsible for ensuring systems and processes to ensure sterility assurance and subsequent to the B100 project phase are developed, adhered to and sustained for routine commercial operations in alignment with established project strategies and plans. This position is responsible for providing expertise, quality oversight and guidance with regards to established requirements. The candidate will be an integral part of the B100 project team and participate in project workstreams, ensure proper execution of qualification/validation strategies as well as providing support for the quality processes and procedures. The incumbent is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices.

• Support the implementation and quality oversight of sterility assurance programs pertaining to B100 licensure, start-up and lifecycle management. This includes supporting implementation of the following sterility assurance programs in B100: Environmental Monitoring, Critical Utilities, EM Validation, Contamination Control and Aseptic Process Simulations
  
• Actively participates in project work stream meetings, planning and scheduling meetings and any related B100 requirements to ensure effective planning and execution of key sterility assurance deliverables.
  
• Review and approve critical project documentation including raw data packages, protocols and final reports across all sterility assurance programs.
  
• Review, approve and maintain records of test requisitions for critical utilities and environmental monitoring sampling.
  
• Development and maintenance of risk assessments including creation of B100 HACCP for aseptic processes.
  
• Creation and approval of APSS protocol(s) and report(s) along with oversight of APSS execution.
  
• Development and deployment of sterility assurance training to key stakeholders.
  
• Create, review, assess and approve change controls, non-conformances and corrective action plans resulting from sterility assurance studies and/or monitoring results.
  
• Supports integration of B100 sterility assurance programs with site sterility assurance team including implementation of MASTER, MODA and LIMS.
  
• Other project tasks as assigned.
  
• Provide shop floor sterility assurance support to B100 project to ensure programs remain in a state of control. Support inspection readiness activities as required.
  

• Bachelors degree required
  
• 3 or more years experience in a biologic space
  
• Proficient with SA experience on the shop floor
  

• 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