Director, International Commercial Quality

Position Overview:  

• Provides strategic direction and management support for Insulet Corporation’s quality system, quality teams and activities, and quality support for international commercial organizations, primarily in Europe, the Middle East and Asia Pacific. 

• Assures compliance with applicable quality management systems regulations and standards in applicable international geographies, and the execution of corresponding QMS activities.  

• Interfaces with other Insulet functions as well as with suppliers, partners, customers and other external parties on issues related to quality. 

Responsibilities:  

• Serve as primary point of contact between Insulet’s international regional commercial organizations and the global quality organization and quality management processes. Serves as critical link in the communications between the larger QARA Team and the in-country and in-region commercial organizations for customer issues, escalations, etc. 

• Host and support commercial and regional focused audits (internal, notified body, regulatory agency). 

• Ensure Quality oversight of distributors, including Quality Agreements, auditing, training, performance monitoring. 

• Ensure that internal and external stakeholders in the regional commercial context understand and execute to post-market obligations (e.g., complaint handling, field actions). 

• Partner with the Global Product Monitoring team on execution of Field Actions as needed. 

• Partner with Global Quality Management Systems team to ensure regional QMS is suitable and compliant with local requirements. 

• Partner with Regulatory team to monitor, escalate, and adapt to changes regional regulatory landscape.  Liaison with in-country and in-region industry associations and regulatory bodies. 

• Provide advice, oversight, and execution support for in-country or in-region labeling requirements, as needed (e.g., license numbers, NB numbers, translation augmentation, etc). 

• Resource for in-country or in-region warehouse and distribution center oversight and partnership from Quality perspective. 

• Delivers Quality related insights from both country and regional perspectives to product and project teams, supporting market expansion efforts. 

• Provide oversight of regional CAPA process, chair regional CAPA Review Board, and ensure overall Regional CAPA system effectiveness. 

• Coordinates quality activities supporting international market expansion. 

• Measure and evaluate quality system effectiveness with emphasis on preventive action. Suggest methods for improving product quality, documentation, and quality system processes. 

• Perform Quality