Manager, Product Quality Complaint Data Analytics

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.

What You'll Do

• 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.
• Evaluate the effectiveness of CAPAs and quality improvements through product surveillance and trend analysis.
• Develop and maintain global surveillance procedures, work instructions, and quality system documentation related to product complaints supporting FDA, 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Who You Are

You have a minimum of a Bachelor's degree in related discipline as well as a minimum of 8 years of experience in Quality Assurance, Product Quality, Post-Market Surveillance, or Product Quality Complaint Analytics, including demonstrated experience in data analytics, metrics, reporting, and continuous improvement.

• A minimum of 3 years of experience leading a highly collaborative team is required.
• Experience leading Post-Market Surveillance, Quality Engineering, or Product Quality activities in a regulated industry.
• Experience managing projects, technical staff, and cross-functional initiatives.
• Experience with complaint handling, investigations, trending, and product performance monitoring.
• Experience developing complaint metrics, statistical trending methods, and action/alert thresholds.
• Working knowledge of FDA Quality System Regulations, cGMPs, Good Documentation Practices, ISO 13485.
• Experience supporting deviations, CAPAs, Management Review, and continuous process improvement.
• Experience with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools, highly preferred.
• Excellent analytical, communication, organizational, and problem-solving skills.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).