Reference No. R2739966

Position Title: Manager, Operational Quality (Shop floor Quality and eBR reviewer)

Duration: Fixed-Term - Contract End Date: Au29, 2025

Department: B100 Operational Readiness

Location: Toronto, Ontario

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 Manager, Quality & Operational Readiness within our building 100 Operational Readiness, will be responsible for ensuring all quality related activities for the Building 100 project phase are developed, managed, followed and sustained for eventual routine manufacturing operations. The incumbent is expected to provide direction and guidance for quality related issues encountered as part of the overall project.

• Ensuring timely review, follow-up on, and approval of executed electronic batch records (eBR, ESPs), and product batch related records.
• Ensuring eBR process complies with GMP and regulatory requirements.
• Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.
• Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.
• Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.

• Bachelor of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.
• Experience interacting with regulatory agencies and health authority inspections is required.
• Ability to work independently as well as part of a team. Organizational skills, flexibility and efficiency are essential.
• Commit to Customers, Develop People, Make Decisions, Lead Teams.
• Key technical competencies and soft skills: Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability.

• 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 andwellness programs and at least 14 weeks' gender-neutral parental leave.