Quality Issue Lead - FSP in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Issue Lead - FSP in the United States.

This role sits at the center of clinical quality operations, ensuring that quality events are accurately identified, assessed, and investigated within strict regulatory timelines. You will act as a key driver of compliance and operational excellence across global clinical trial activities, helping ensure issues are properly escalated, documented, and resolved. Working within a highly regulated GCP/GxP environment, you will lead end-to-end quality event management, from triage through root cause analysis and CAPA oversight. The position requires strong analytical thinking, regulatory awareness, and the ability to collaborate across multidisciplinary clinical teams. You will also contribute to continuous improvement initiatives, enhancing case management processes and quality systems. This is a high-impact role where your work directly supports patient safety, data integrity, and inspection readiness across clinical development programs.

In this role, you will oversee the identification, classification, and management of quality events, ensuring all cases are assessed accurately and handled within required timelines and compliance standards. You will lead investigations, coordinate stakeholders, and ensure proper escalation of critical issues while maintaining rigorous documentation within eQMS systems.

• Review and classify submitted quality issues to determine whether they meet Quality Event thresholds
• Ensure timely triage, documentation, and escalation of critical events to management and regulatory stakeholders
• Lead root cause analysis, gap analysis, and due diligence investigations for confirmed quality events
• Review SOPs, study documentation, and supporting records to assess process deviations and impact
• Assemble cross-functional teams to support investigations and validate findings
• Oversee CAPA development, implementation, and effectiveness tracking for quality, audit, and inspection findings
• Monitor risk mitigation actions and evaluate their ongoing effectiveness across clinical operations
• Contribute to process improvement initiatives, training materials, and case management enhancements

This position requires strong experience in clinical quality, regulatory compliance, and GCP/GxP environments, with the ability to manage complex investigations and drive structured problem-solving. You should be highly analytical, detail-oriented, and confident working across cross-functional clinical and regulatory teams.

• Bachelor’s degree with 7+ years of experience, or Master’s/MBA with 6+ years of experience
• At least 5 years of pharmaceutical or clinical research experience in GCP/GxP quality, data management, or regulatory operations
• Strong knowledge of clinical trial processes, SOPs, and global regulatory requirements
• Experience with quality event management, CAPA systems, and inspection readiness activities
• Background in root cause analysis, process improvement, and structured investigation methodologies
• Exposure to regulatory inspections and compliance audits strongly preferred
• Strong project management, communication, and stakeholder coordination skills
• Familiarity with continuous improvement approaches (e.g., Lean Six Sigma) is a plus

• Competitive compensation aligned with experience and market benchmarks
• Comprehensive health coverage (medical, dental, and vision)
• Retirement savings plans with employer contributions (where applicable)
• Flexible work arrangements depending on role and project needs
• Paid time off, holidays, and leave programs
• Career development in global clinical research and quality operations
• Exposure to large-scale clinical programs and regulatory inspection environments
• Opportunities for training, upskilling, and continuous improvement initiatives