Quality Issue Lead - FSP 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 Issue Lead - FSP in Canada.

This role plays a critical part in ensuring the integrity, compliance, and continuous improvement of clinical quality processes within a global clinical research environment. You will be responsible for evaluating, classifying, and managing quality events, ensuring that issues are properly assessed, escalated, and investigated in alignment with GCP and regulatory requirements. Operating in a highly regulated and detail-oriented setting, you will lead end-to-end case management activities, from initial triage through root cause analysis and CAPA oversight. This position offers the opportunity to work cross-functionally with clinical, operational, and quality stakeholders to ensure timely resolution of complex quality issues. You will also contribute to process improvements, risk mitigation strategies, and the development of standardized quality frameworks. It is an impactful role suited for a quality-driven professional who thrives in structured environments and is passionate about driving compliance and operational excellence in clinical research.

• Review, assess, and classify submitted quality events to determine whether they meet established thresholds and require formal investigation or escalation.
• Manage end-to-end quality event case workflows, ensuring timely documentation, triage, and progression through investigation stages in compliance with regulatory standards.
• Initiate and conduct root cause analysis, gap analysis, and due diligence investigations to identify underlying issues and deviations from expected processes.
• Escalate critical quality events to management and ensure appropriate stakeholders are informed through formal notification processes.
• Collaborate with subject matter experts and cross-functional teams to gather documentation, validate findings, and confirm event details.
• Oversee CAPA development, implementation, and effectiveness checks, ensuring corrective and preventive actions are appropriately tracked and validated.
• Monitor risk mitigation actions and evaluate their effectiveness, identifying trends and potential impacts on business and compliance outcomes.
• Contribute to continuous improvement initiatives, including process optimization, system enhancements, and development of quality management tools.
• Support the creation of guidance materials, training documentation, and standardized procedures for quality issue management.
• Analyze quality data and performance trends to identify opportunities for operational improvements and risk reduction.

• Bachelor’s degree with 7+ years of relevant experience, or Master’s degree/MBA with 6+ years of experience in pharmaceutical, clinical research, or regulated environments.
• Minimum of 5 years of experience in clinical operations, GCP quality, GxP quality, data management, or regulatory compliance functions.
• Strong knowledge of clinical trial processes, GCP requirements, SOPs, and applicable regulatory frameworks.
• Experience conducting or supporting regulatory inspections and managing inspection-related activities.
• Strong background in quality issue management, root cause analysis, and CAPA development.
• Experience with process and system management in a regulated clinical or pharmaceutical environment.
• Strong analytical and problem-solving skills with attention to detail and accuracy.
• Excellent communication skills with the ability to interact effectively across technical and non-technical stakeholders.
• Ability to manage multiple priorities in a structured, deadline-driven environment.
• Experience with continuous improvement methodologies (e.g., Lean Six Sigma) is a strong asset.

• Competitive compensation aligned with experience and industry standards.
• Fully remote work flexibility within Canada and the United States (depending on eligibility).
• Comprehensive health, dental, and vision insurance coverage.
• Opportunity to work in a global clinical research environment with high-impact projects.
• Exposure to advanced quality systems, regulatory processes, and continuous improvement initiatives.
• Career development opportunities within a leading global clinical research organization.
• Collaborative and mission-driven culture focused on improving patient outcomes.
• Participation in structured training and professional development programs.
• Inclusive workplace committed to diversity, equity, and equal opportunity employment.