Team Lead Site Investigation

Job Summary
This role is for an Investigation and CAPA Governance Lead, responsible for overseeing incident management, deviation investigations, and CAPA execution across manufacturing and quality operations. The position ensures structured, timely, and compliant investigation practices, drives cross-functional collaboration, and maintains audit readiness through robust documentation and proactive risk management.
Roles & Responsibilities
• You will be responsible for ensuring all team members have the necessary tools and resources for accurate and timely incident logging, with periodic reviews to verify correct categorization and immediate correction of discrepancies.
• You will be responsible for supervising risk assessments to identify the potential impact of each incident on batches, equipment, facilities, calibrations, and validations, including patient safety and compliance status.
• You will be responsible for facilitating prompt escalation of critical events such as FARs or recalls, while coordinating with Compliance and Regulatory Affairs teams to evaluate broader regulatory implications.
• You will be responsible for leading cross-functional brainstorming sessions to identify potential causes and coordinating comprehensive data collection including batch records, interviews, quality data, and SOPs.
• You will be responsible for guiding data verification, analysis, and root cause identification using statistical tools, hypothesis testing, and literature research, ensuring well-supported and scientifically sound conclusions.
• You will be responsible for collaborating with stakeholders to develop effective CAPA plans, monitoring their execution, evaluating outcomes through repeat assessments, and enabling horizontal deployment where needed.
• You will be responsible for reviewing investigation reports to ensure structural clarity, data integrity, SOP adherence, and stakeholder alignment, while maintaining audit readiness across sites.
• You will be responsible for conducting incident/OOS/OOT/market complaint trending, identifying top contributors, proposing action plans to reduce recurrence, tracking SLA adherence, and implementing initiatives to improve turnaround time (TAT).