Supervisor, Sterility Assurance

Job Summary

The Supervisor, Sterility Assurance is responsible for providing technical direction and support within a pharmaceutical manufacturing environment with respect to environmental monitoring (EM), clean utilities monitoring, and other sterility assurance activities and programs. The incumbent is responsible for the management, training, and development of Microbiologists to ensure all work is performed in compliance with regulatory, compendial, and safety requirements.

Job Responsibilities

• Defend the environmental monitoring and clean utilities monitoring programs during regulatory audits (acting as a primary point of contact) and interact with regulatory agencies and professional colleagues to ensure compliance with applicable requirements
• Ensure all sterility assurance activities, including routine and non‑routine environmental monitoring and clean utilities monitoring, are performed according to defined schedules
• Ensure all work is performed in compliance with cGMP, GLP, established procedures, safety standards, compendial, and regulatory requirements
• Provide technical direction and support related to environmental monitoring and clean utilities monitoring activities, applying sound scientific principles to resolve issues as they arise
• Provide technical guidance and direction for sterility assurance projects, including environmental monitoring qualification studies, clean utilities qualification studies, onboarding of environmental monitoring media, and cleaning and disinfection studies, while coordinating with cross‑functional partners
• Establish and coordinate training and development plans for staff by identifying training needs, assigning work based on qualifications, and providing coaching and feedback
• Identify, recommend, and implement opportunities to improve quality and productivity within the department
• Review sterility assurance protocols, summary reports, trend reports, and limit assessments
• Ensure a safe working environment through enforcement of safety practices and regulations
• Liaise with procurement to support sourcing of cost‑effective consumables
• Promote quality objectives by aligning and engaging staff and ensuring compliance with internal and regulatory standards
• Translate departmental objectives into team and individual performance goals
• Lead performance discussions with direct reports, including regular one‑on‑one meetings, feedback, and performance expectation alignment
• Build trust‑based relationships through open, two‑way communication with employees and internal stakeholders
• Support hiring and onboarding of new team members as required
• Ensure adherence to all compliance programs, company policies, and procedures
• Perform other duties as assigned

Job Requirements

Education

• Bachelor’s degree from a recognized institution in Biology, Microbiology, Applied Pharmaceutical Sciences, Engineering, or a related discipline

Knowledge, Skills, and Abilities

• Strong communication, interpersonal, and relationship‑management skills
• Demonstrated leadership capability
• Strong technical writing and verbal communication skills
• Comprehensive understanding of current GMP regulatory requirements (FDA, EU, ICH, ISO, Annex 1)
• Experience supporting FDA, Health Canada, or equivalent regulatory inspections
• Ability to work effectively in a fast‑paced pharmaceutical environment
• In‑depth understanding of compendial requirements, regulations, and standards related to sterility assurance

Experience

• Minimum 2–3 years of supervisory or people‑leadership experience
• Minimum 5–7 years of experience in a GMP pharmaceutical, microbiology, or environmental monitoring environment
• Sterile manufacturing experience is an asset

Salary Range: $100,000 – $120,000