Quality Issue Lead - FSP

• Driving QE case management, ensuring investigations are conducted thoroughly within timelines and compliance requirements
• Triage submitted cases to ascertain if Quality Event (QE) threshold has been met
• Manage confirmed QE case through investigation process including root cause analysis
• Review and classification of submitted quality issues
• Complete necessary documentation in eQMS system
• Initiate appropriate escalation of Critical QEs when necessary
• Apply root cause analysis, gap analysis, and/or due diligence investigation
• Contribute to process development and improvement for case management
• Develop and implement guidance documents and training
• Monitor CAPA completion and tracking of effectiveness
• Track and ensure implementation of risk mitigations and evaluate potential impacts to business

• BS – 7+ years or equivalent
• MS/MBA – 6+ years or equivalent
• Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
• Regulatory inspection experience
• Process and system management experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities are required
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred

Strong background in continuous improvement methodology (i.e., Lean Six Sigma)