Lead, Sterility Assurance

Job Summary

The Sterility Assurance Lead is accountable for maintaining a sustained state of sterility assurance at the Richmond Hill site, and serves as the site technical authority for the contamination control strategy and aseptic processing operations. This role is responsible to ensure regulatory inspection readiness, owns the Contamination Control Strategy lifecycle, governs sterility?impacting changes, and ensures alignment with Annex 1 and global regulatory expectations. This role involves managing daily operations, driving continuous improvement initiatives, sterility assurance related investigations and providing expert technical support to ensure compliance with corporate and site sterility assurance standards.

This role partners closely with Quality, Manufacturing, Engineering, Validation and other cross?functional teams to ensure sterility assurance principles are embedded into day?to?day operations, change management, and long?term site strategy.

Job Responsibilities

• Accountable for maintaining the Richmond Hill site in a sustained state of contamination control, ensuring continuous inspection readiness.
• Own, govern, and continuously improve the site Contamination Control Strategy (CCS), ensuring alignment with Annex 1 lifecycle expectations and Quality Risk Management principles.
• Act as a site technical authority for sterility assurance decisions, including risk acceptance, requalification strategy, and sterility assurance impact assessments.
• Ensure all sterility assurance programs remain compliant with current and evolving regulatory requirements (FDA, HPFB, EC, ICH, ISO, EU GMP Annex 1).
• Provide overall governance and lifecycle management of contamination control programs.
• Lead the media fill and facility and utility requalification programs to ensure robust design, execution, maintenance, and regulatory defensibility.
• Serve as a site sterility assurance lead during regulatory inspections and audits, providing subject matter expertise and technical defense of sterility assurance programs.
• Provide oversight and technical approval for investigations related to sterile operations, environmental monitoring excursions, clean utilities, and contamination events.
• Ensure investigations demonstrate robust root cause analysis and that CAPAs are appropriate, sustainable, and effective.
• Assess change controls, including equipment, utilities, processes, materials, suppliers, and facility modifications for sterility assurance impact.
• Periodically review sterility assurance lifecycle risk assessments and ensure alignment with site and corporate risk tolerance.
• Coordinate execution of Environmental Monitoring Performance Qualification (EMPQ) and Clean Utilities Performance Qualification (PQ) activities.
• Generate and review EM and clean utility trending reports and periodic limit assessments.
• Prepare and approve sterility assurance validation protocols and summary reports.
• Provide sterility assurance expertise and quality input to site engineering projects and capital initiatives.
• Work cross?functionally to build organizational understanding and capability in contamination control and aseptic processing.
• Support business planning processes by identifying emerging risks, future capability needs, and opportunities for continuous improvement.
• Mentor and coach operational and technical staff on sterility assurance principles, aseptic behavior, and contamination control requirements.
• Oversee and contribute to the design and delivery of site training to strengthen sterility assurance culture and technical competence.
• Perform other duties as assigned.

Job Requirements

• Education

• Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering or related discipline.

• Knowledge, Skills and Abilities
  • Working knowledge of media fills, smoke studies, aseptic manufacturing, environmental monitoring, clean utilities, contamination control and microbiology.
  • Strong technical writing, oral and written communication skills.
  • Comprehensive understanding of current and evolving regulatory requirements (FDA, EU, ICH, ISO, Annex 1).
  • Demonstrated communication, interpersonal and relationship management skills.
  • Experience with US FDA and Health Canada (or equivalent) regulatory inspections.
• Experience
  • Minimum 7 years of experience in a GMP production environment.
  • Minimum 4 years of sterile manufacturing experience required.