Compliance

• Lead and/or support Quality harmonization, optimization and improvement projects
• Draft and maintain quality plans, including controlled templates and liaising with cross functional teams to ensure plan implementation and closure
• Support Post Market activities, as needed, including complaint intake, investigation, and trending
• Support the CAPA process as needed, including managing CAPAs and ensuring timely completion, providing support during investigation, contributing to determination of corrective and preventive actions, implementation strategy, and determining statistical based verification of effectiveness criteria, where applicable
• Support CAPA Review Board facilitation, as needed, driving execution and escalation
• Support Configuration Management and Quality System Training activities, as needed, including change control and direct/indirect labor training
• Monitor and enhance quality metrics, as needed; execute actions in response to signals
• Support the organization and facilitation (front and back room) of FDA and Notified Body audits and inspections, as needed
• Support Management Review, as directed
• Partner with Regulatory to execute compliance related strategies, as directed
• Partner with technical teams to ensure quality system enables success while maintaining compliance
• Support implementation of corporate strategic initiatives at site level, as directed
• Lead and/or support HHE content creation and compilation, liaising cross-functionally to ensure accuracy and alignment
• Ensure continuous improvement, efficiency and compliance with internal and external requirements
• Guide users and stakeholders in the implementation of the HHE process and procedures and perform local training as needed; ensure alignment between corporate and local procedures
• Ability to professionally and thoroughly present HHE content and data to support HRC in understanding the risk and extent of field issues for decision-making and execution of internal and external action.

Principal Quality Compliance Specialist

Compliance Director – Diabetes

Senior Director, Trading Compliance

Ethics & Compliance Director

Senior Global Compliance Director – CQS