Quality Issue Lead - FSP in Brazil, Indiana at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Issue Lead - FSP based in Brazil.

This role is critical within a global clinical research environment, focused on ensuring the proper identification, investigation, and resolution of quality events across clinical trial operations. The professional will act as a key driver of compliance and quality excellence, overseeing the full lifecycle of issue management—from triage and classification to root cause analysis and CAPA execution. Working closely with cross-functional teams, this position ensures that quality issues are handled efficiently, escalated appropriately, and fully documented in accordance with GCP and regulatory standards. The environment is highly regulated, detail-oriented, and collaborative, requiring strong analytical thinking and a proactive approach to risk mitigation. This role has a direct impact on patient safety, data integrity, and the overall success of clinical studies.

• Review, classify, and triage submitted quality issues to determine whether they meet Quality Event (QE) thresholds and require escalation
• Ensure timely and compliant investigation of quality events, including documentation in eQMS systems and alignment with regulatory expectations
• Lead root cause analysis, gap analysis, and due diligence activities to fully understand and document quality issues
• Coordinate with SMEs and study teams to gather evidence, confirm event details, and ensure complete investigation coverage
• Escalate critical quality events to senior management through formal notification processes when required
• Monitor CAPA development, implementation, and effectiveness checks to ensure corrective and preventive actions are working as intended
• Track risk mitigation actions and assess their impact on operational and compliance performance
• Contribute to process improvement initiatives, including development of tools, methodologies, and training materials for issue management
• Analyze quality trends and support continuous improvement efforts across clinical quality systems

• Bachelor’s degree with 7+ years of experience, or Master’s/MBA with 6+ years of experience in a relevant field
• Minimum 5 years of pharmaceutical or clinical research experience in GCP, GxP, quality management, or data/operational compliance
• Strong knowledge of clinical trial processes, GCP requirements, SOPs, and regulatory inspection environments
• Experience in quality event management, root cause analysis, and CAPA systems
• Background in process and system management within regulated environments
• Strong analytical and problem-solving skills with attention to detail and data accuracy
• Experience working with cross-functional global teams in clinical or pharmaceutical settings
• Project management and stakeholder coordination capabilities
• Knowledge of continuous improvement methodologies (e.g., Lean Six Sigma) is a plus
• Strong communication skills, both written and verbal, in a highly regulated environment

• Competitive compensation package aligned with industry standards
• Remote work flexibility across Brazil and other LATAM locations
• Opportunity to work in a global clinical research organization
• Exposure to international clinical trials and regulatory frameworks
• Career development within a highly specialized quality and compliance function
• Participation in large-scale transformation and process improvement initiatives
• Collaborative, science-driven, and patient-focused work environment
• Access to continuous learning and professional development opportunities