Reference No. R2769638

Position Title: Manager - Operational Quality- Vaccines

Department: QC and Technical Services

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.

As a member of the Quality Operations, Operational Quality team, this role will provide compliance support to Deputy Directors for the licensed product, support teams in managing their day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices. The incumbent will provide Operational Quality support Deputy Directors for designated departments of Industrial Operations (such as: Bulk Manufacturing, Formulations Filling & Packaging, Media Services, Manufacturing, Quality Control, Global Engineering Maintenance, Materials Management/Logistics, Purchasing and Customer Service/Marketing, Manufacturing Technology, QOSA). The incumbent is expected to work independently as a QO Manager with a level of autonomy and authority for decision making as a delegate to the Deputy Director as necessary to drive process improvements, ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.

• Support the Operational Quality Deputy Directors in ensuring timely review, follow-up on, closure and approval of various documents, such as: master and executed batch records, operational log books, sterilization and depyrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope or delegated.
  
• Ensure failure investigations/deviations are processed and that problem resolution occurs prior to commitment date within SAP. Ensure that batch recommendations are based on sound science and supporting reports are of high quality. Ensure timely review of deviation, and approve notation and minor deviations.
  
• Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR's) and CAPA for IO, as designated within this process. This activity will require the incumbent to determine if a change request impacts product and processes.
  
• In addition, the incumbent might have to be a QO Representative at various internal and external committees and board related to the management of the organization, such as: Sanofi Pasteur Change Control Board, Material Review Board.
  
• Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close contact with the various departments.
  
• In conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.
  
• Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
  
• Make assessment decision and authorization for processing / reworking, manufacturing at risk.
  
• Perform data gathering and analysis of non-conformances to support annual product review.
  
• Project team participation
  

• Bachelor of Science with 5 or more years of relevant experience in pharmaceutical or biological manufacturing.
  
• Minimum of 5 years knowledge of quality compliance in a GMP regulated environment.
  

• 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