Manager, Product Quality Complaint Data Analytics

Insmed; New York (NY); On-site; USD 124,000 - 161,000; Full time

Job summary

Insmed seeks a Manager of Product Quality Complaint Data Analytics to lead governance, analytics, and continuous improvement of the global complaint program. The role involves developing analytical frameworks for trend identification, managing a direct report, and partnering across functions to support quality investigations and regulatory compliance.

The position manages a QA Sr Product Complaint Specialist and collaborates across clinical and commercial teams to improve complaint handling and

Qualifications

• Bachelor's degree in related discipline.
• Minimum 8 years in Quality Assurance, Product Quality, or Post-Market Surveillance.
• Minimum 3 years leading collaborative teams.
• Experience with complaint handling, investigations, and product performance monitoring.
• Knowledge of FDA Quality System Regulations, cGMPs, and ISO 13485.
• Proficiency with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools preferred.
• Strong analytical, communication, and problem-solving skills.

Responsibilities

• Lead Product Quality Complaint Analytics function including metrics, trending, and Veeva system support.
• Manage and coach QA Sr Product Complaint Specialist with performance and professional development oversight.
• Develop and maintain statistical processes for complaint trending and establish action thresholds.
• Support product launches and continuous improvement of complaint management across clinical and commercial products.
• Perform statistical analyses supporting investigations, CAPAs, Management Review, and quality decision-making.

Skills

Analytics

Quality Assurance

Problem-solving

Communication

Education

Bachelor's degree

Tools

Veeva Vault QMS

Qlik

Minitab

Job description

Insmed seeks a Manager of Product Quality Complaint Data Analytics to lead governance, analytics, and continuous improvement of the global complaint program. The role involves developing analytical frameworks for trend identification, managing a direct report, and partnering across functions to support quality investigations and regulatory compliance.

Responsibilities

• Lead Product Quality Complaint Analytics function including metrics, trending, and Veeva system support
• Manage and coach QA Sr Product Complaint Specialist with performance and professional development oversight
• Develop and maintain statistical processes for complaint trending and establish action thresholds
• Support product launches and continuous improvement of complaint management across clinical and commercial products
• Perform statistical analyses supporting investigations, CAPAs, Management Review, and quality decision-making

Requirements

• Bachelor's degree in related discipline
• Minimum 8 years in Quality Assurance, Product Quality, or Post-Market Surveillance
• Minimum 3 years leading collaborative teams
• Experience with complaint handling, investigations, and product performance monitoring
• Knowledge of FDA Quality System Regulations, cGMPs, and ISO 13485
• Proficiency with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools preferred
• Strong analytical, communication, and problem-solving skills

Compensation

$124,000-$161,000 annual