Quality Issue Lead - FSP

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.

Accountabilities

• 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

Requirements

• 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

Benefits

• 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

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1