IssueLead-FSP

## 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 comp