QualityIssueLead-FSP

## 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