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 an Issue Lead – FSP based in Brazil.

This role plays a critical part in ensuring the quality and compliance of global clinical trial operations by leading the identification, assessment, and investigation of quality events.
You will be responsible for triaging and managing quality issues, ensuring they are accurately classified, escalated when necessary, and resolved within required timelines.
The position involves conducting structured investigations, including root cause and gap analysis, while coordinating with cross-functional teams and subject matter experts.
You will also oversee case management processes within electronic quality systems, ensuring data integrity and regulatory compliance.
A key part of the role is driving continuous improvement by analyzing trends, supporting CAPA development, and strengthening quality systems.
You will collaborate with global stakeholders to ensure consistency, efficiency, and compliance across GCP and GxP processes.
This is a high-impact quality role where analytical rigor and process ownership directly safeguard clinical trial integrity and patient safety.

Accountabilities:

• Review, classify, and triage submitted quality events to determine whether QE thresholds are met and ensure appropriate categorization and documentation in eQMS systems.
• Manage confirmed quality events through the full investigation lifecycle, including root cause analysis, gap analysis, and due diligence assessments.
• Ensure timely escalation of critical quality events to senior management and regulatory stakeholders through formal notification processes.
• Coordinate and lead cross-functional investigation teams, engaging SMEs and study stakeholders to validate event details and findings.
• Monitor CAPA development, implementation, and effectiveness checks to ensure corrective and preventive actions are functioning as intended.
• Track risk mitigation actions and evaluate their impact on clinical operations and quality outcomes.
• Contribute to process improvement initiatives, including development of guidance, tools, and training materials for quality event management.

Requirements:

• Bachelor’s degree with 7+ years of experience, or Master’s degree/MBA with 6+ years of relevant experience.
• Minimum 5 years of experience in pharmaceutical, clinical operations, GCP/GxP quality, data management, or regulatory environments.
• Strong knowledge of clinical trial processes, GCP requirements, and applicable SOPs and regulatory frameworks.
• Experience with quality event management, audits, or regulatory inspections is highly desirable.
• Proven ability to conduct root cause analysis, gap analysis, and structured investigations.
• Strong project management, organizational, and problem-solving skills in complex, matrixed environments.
• Familiarity with continuous improvement methodologies such as Lean or Six Sigma is a plus.
• Excellent communication skills with the ability to work effectively across global, cross-functional teams.

Benefits:

• Competitive compensation aligned with clinical quality and operations expertise
• Opportunity to work in global clinical quality and compliance programs
• Remote-friendly work arrangements depending on assignment
• Exposure to international regulatory inspections and quality systems
• Career development in quality assurance, GCP compliance, and process improvement
• Participation in high-impact initiatives improving clinical trial integrity
• Collaborative global environment with cross-functional learning 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