Manager, Product Quality Complaint Data Analytics

About the role

The Manager, Product Quality Complaint Data Analytics, reports to the Director of Product Quality Complaints and is responsible for leading the governance, analytics, reporting, system support, and continuous improvement of Insmed's global Product Quality Complaint program. This role serves as the business and technical subject matter expert for complaint analytics, reporting, Veeva system enhancements, process improvements, and complaint surveillance. The position is accountable for developing and maintaining the analytical framework used to identify product quality trends, evaluate complaint data, and support Management Review and executive decision-making. The Manager partners with Product Quality Complaints, QA Operations, Technical Operations, DSPV, Quality Systems, and Patient Services to support product quality investigations, implement system enhancements, and drive continuous process improvements. The position will be based in Bridgewater, NJ HQ (onsite 3 days a week).

Responsibilities

• Lead the Product Quality Complaint Analytics function, including complaint analytics, reporting, metrics, trending, Veeva system support and enhancements, process improvements, and Management Review reporting.
• Lead and manage the QA Sr Product Complaint Specialist, providing technical leadership, coaching, performance management, and professional development to direct reports.
• Establish team priorities, manage workload, allocate resources, and ensure timely completion of metrics activities and assigned projects.
• Support new product launch, and continuous improvement of Insmed's Product Quality Complaint Management process across clinical and commercial products, including complaint intake, evaluation, investigation, trending, and regulatory compliance for drug, device, and combination products.
• Establish and maintain statistical processes for complaint trending, action, and alert thresholds.
• Develop and maintain complaint analytics to support product performance monitoring, Management Review, and identification of potential quality trends.
• Support the development and implementation of automated reporting, data visualization, and other analytical tools.
• Oversee development and maintenance of KPIs and metrics supporting Product Quality Complaints Management Reviews.
• Provide technical support for signal detection activities and ensure identified quality signals are appropriately escalated through investigations, CAPAs, or product assessments, as applicable.
• Perform and/or oversee statistical analyses supporting complaint investigations, deviations, CAPAs, Management Review, and quality decision-making.