Quality Assurance Supervisor
About The Position
At ITR Laboratories Canada Inc., our mission is to bring new medicines to the world and help improve the health and well-being of individuals across the globe. For over 35 years, ITR has been a trusted partner to the pharmaceutical and biotechnology industries, providing high-quality drug safety assessment services that support the development of innovative therapies. Our commitment to scientific excellence, animal welfare, regulatory compliance, and continuous improvement makes ITR a recognized leader in preclinical research services worldwide. We are seeking an experienced Quality Assurance Supervisor to lead and coordinate Quality Assurance activities in a preclinical regulated laboratory and animal model research environment. Reporting to the Quality Assurance Manager, this position is responsible for overseeing daily QA operations, ensuring compliance with GLP, regulatory requirements, and company quality standards.
Requirements
- Bachelor's Degree in Life Sciences, Biological Sciences, Pharmaceutical Sciences, Quality Management, or a related field.
- Minimum 7 years of Quality Assurance experience in a preclinical regulated environment, involving laboratory animal models.
- Experience in quality auditing, quality systems management, validation, CAPA management, and regulatory inspections.
- Experience supporting client, sponsor, and regulatory audits and inspections.
- Strong coaching, mentoring, and training skills.
- Experience in biotechnology, toxicology, safety pharmacology research environments.
- Strong knowledge of: FDA 21 CFR Part 58 and Part 11
- Strong knowledge of: OECD Good Laboratory Practice (GLP)
- Strong leadership and team management skills.
- Excellent auditing, inspection, and problem-solving abilities.
- Effective communication, training, and report-writing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency with Microsoft Office applications.
- Ability to work effectively with diverse teams and stakeholders.
- Strong reading and writing skills in English are mandatory, as all study documentation is produced in English.
- Fluency in French is required for internal communication.
Responsibilities
- Supervise, coach, and support Quality Assurance personnel.
- Coordinate inspections, audits, and QA activities to ensure timelines are met.
- Conduct and oversee quality inspections, audits, and compliance assessments.
- Support Sponsor, Regulatory Authority, and third-party inspections.
- Manage and maintain Quality Management Systems, SOPs, CAPA programs, deviation management, and document control systems.
- Support validation and qualification activities for facilities, equipment and computerized systems.
- Deliver and coordinate QA-related training programs.
- Collaborate with cross-functional departments to promote quality and continuous improvement initiatives.
- Maintain a clean, safe, and organized laboratory environment while adhering to all health and safety procedures.
- Collaborate with Study Directors, Scientists, Principal Investigators, and laboratory staff to ensure study timelines and objectives are achieved.
- Participate in training activities and contribute to continuous improvement initiatives within the Bioanalytical Services Department.
Benefits
- Full-time permanent position (37.5 hours per week)
- Competitive salary based on experience
- Collective Health and Dental Insurance Plan
- RRSP Contribution Program
- Two (2) weeks of vacation
- Opportunities for professional growth and continuous learning
- Collaborative and supportive team environment
- The opportunity to contribute to the development of new medicines that improve lives worldwide
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What This Job Offers
Job Type
Full-time
Career Level
Senior
