Director, Quality Assurance - Regulatory

Job description

Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives. Labcorp is looking for a Director, Quality Assurance – Regulatory, Enterprise Kit Collection Quality Management System (QMS) provides strategic and operational quality leadership for an enterprise-wide specimen collection kit program. This role is accountable for the design, implementation, governance, and continuous improvement of a compliant quality management system supporting the lifecycle of specimen collection kits used across diagnostic and clinical programs. Duties and Responsibilities: List the core tasks and responsibilities associated with the role. - Provide enterprise-wide quality governance for specimen collection kits, ensuring compliance with FDA medical device regulations and ISO 13485 across all functional areas involved in kit lifecycle activities. - Serving as a Management Representative. - Design, implement, and maintain a robust Quality Management System for the centralized specimen collection kit program, including policies...