Quality Assurance Specialist in Canada Creek, Nova Scotia at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Assurance Specialist in Canada.

This role plays a key part in strengthening global quality assurance systems within a regulated clinical research environment. The Quality Assurance Specialist supports the design, implementation, and continuous improvement of QA frameworks that ensure compliance with international standards and regulatory expectations. Working closely with cross-functional teams, the role contributes to audits, inspections, and vendor oversight activities while promoting a culture of quality and accountability. It combines operational QA execution with strategic input on policy development and process optimization. The position also involves guiding teams on best practices, regulatory updates, and quality system enhancements. This is a highly collaborative role with significant impact on compliance, patient safety, and organizational excellence.

The Quality Assurance Specialist is responsible for supporting the planning, execution, and evaluation of global QA activities, ensuring compliance with applicable regulations and internal standards.

• Implement and maintain QA plans, processes, and quality indicators to assess service and product quality
• Conduct and support internal audits, site inspections, and vendor assessments, ensuring timely resolution of findings
• Develop, review, and maintain Quality System documentation, including policies, procedures, and templates
• Lead or support regulatory inspections and sponsor audits, including preparation, coordination, and follow-up activities
• Communicate audit outcomes and support Root Cause Analysis and Corrective and Preventive Actions (CAPA) development
• Provide guidance on regulatory requirements, clinical trial conduct standards, and privacy-related matters
• Collaborate with internal teams and external partners to ensure compliance and continuous improvement
• Support QA process development, training initiatives, and mentoring of junior QA staff

Requirements:
The ideal candidate brings strong expertise in quality assurance within clinical research, life sciences, or a regulated environment, along with excellent analytical and communication skills.

• Undergraduate degree with 4–6 years of relevant experience, or a college diploma with 7–9 years of equivalent experience
• Background in Life Sciences, Clinical Research, Clinical Quality Assurance, or Information Technology preferred
• Strong knowledge of ICH-GCP guidelines and global clinical research regulatory frameworks
• Familiarity with global privacy regulations and compliance requirements
• Proven experience in audits, inspections, and vendor qualification processes
• Strong analytical thinking, problem-solving, and attention to detail
• Ability to interpret regulations and translate them into practical processes and training
• Excellent collaboration and stakeholder management skills

Benefits:

• Competitive compensation package aligned with experience and industry standards
• Flexible work arrangements, including hybrid or remote options depending on role requirements
• Comprehensive health and wellness coverage
• Opportunities for professional development and continuous learning
• Exposure to global clinical research projects and cross-functional collaboration
• Supportive and quality-driven work environment focused on continuous improvement