Manager, Product Quality Complaint Data Analytics at Insmed Incorporated in NJ Corporate Headquarters

Job description

• 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

• In this role, you’ll have the opportunity to 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.
• 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.

Requirements

• 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).

Skills

Required

• Data analytics
• Metrics and reporting
• Continuous improvement
• Statistical analysis
• Complaint handling and investigations
• Project management
• Team leadership

Preferred

• Veeva Vault QMS
• Qlik
• Minitab
• Similar analytics tools

Benefits

• At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
• Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
• $124,000.00-161,000.00 Annual