Microbiology Manager- Pharmaceuticals/Responsable microbiologie–pharmaceutique

Job summary

The Microbiology Manager oversees daily laboratory operations, staff supervision, and ensures all testing complies with regulatory and quality standards. They are responsible for method validation, quality control implementation, and serving as a subject matter expert during audits and inspections.

Job details

Role Description The Microbiology Manager – Pharmaceuticals / Responsable microbiologie – pharmaceutique is a full-time, on-site role based at Pathogenia Lab in Dorval, QC. This role oversees microbiology operations in a pharmaceutical testing environment, including planning, organizing, and supervising daily laboratory activities and staff. The manager ensures that microbiological testing related to pharmaceutical products complies with regulatory requirements, internal quality standards, and client specifications. Key responsibilities include developing and validating microbiological methods, reviewing and approving test results, implementing and monitoring quality control and quality assurance procedures, and ensuring proper sterilization practices. The role also involves training and mentoring team members, coordinating with cross-functional partners, optimizing workflows and resource utilization, and contributing to continuous improvement initiatives and audits. The manager support product and process validation activities (media fill studies, disinfectant efficacy studies, growth promotion testing) and serve as SME during internal audits, client audits, and regulatory inspections (FDA, Health Canada, ISO17025) Qualifications Strong microbiology expertise, including pharmaceutical microbiology and applied food or environmental microbiology. Proficiency in core laboratory skills such as aseptic technique, sample preparation, and operation of microbiological instrumentation. Experience with quality control activities, including monitoring test performance, interpreting trends, and addressing deviations. Knowledge of sterilization methods and contamination control in laboratory and production environments. Background in quality assurance systems, including SOP development, documentation, CAPA processes, and regulatory compliance. Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related field. 5+ years of microbiology experience in a pharmaceutical, biotech, or regulated GMP laboratory setting, including 2+ years in a supervisory/management role Ability to work efficiently in an on-site, fast-paced environment, manage multiple priorities, and meet tight deadlines. Strong analytical, organizational, and communication skills; ability to document findings clearly and collaborate across disciplines. Experience leading or supporting regulatory inspections and audits and Strong root-cause investigation and CAPA writing skills

What you’ll do

The Microbiology Manager oversees daily laboratory operations, staff supervision, and ensures all testing complies with regulatory and quality standards. They are responsible for method validation, quality control implementation, and serving as a subject matter expert during audits and inspections.

Requirements

Candidates must hold a Bachelor's or Master's degree in a relevant scientific field and possess at least 5 years of microbiology experience in a regulated GMP environment. A minimum of 2 years in a supervisory role is required, along with strong expertise in pharmaceutical microbiology and regulatory compliance.

Listed skills

• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Quality Control · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Microbiology
• Pharmaceutical testing
• Aseptic technique
• Quality control
• Quality assurance
• SOP development
• CAPA
• Regulatory compliance
• Sterilization methods
• Contamination control
• Method validation
• Root-cause investigation
• Laboratory management
• GMP
• ISO17025
• Auditing

Job areas

• Science & Research
• Management & Leadership
• Healthcare
• Manufacturing