The Vice President, Quality Assurance is responsible for the Quality Assurance function of Sirtex Medical Inc. and its subsidiary entities, and serves as a leader for Sirtex's currently marketed products, products in all stages of internal pipeline development, and products that may be acquired by Sirtex from third parties. This role ensures that the quality management system is developed, maintained and applied in a practical, coordinated and effective manner for both medical device and pharmaceuticals, in alignment with company requirements and objectives, and in compliance with  all applicable regulations and standards.Reporting to the Senior Vice President, Quality and Regulatory Affairs, the Vice President, Quality Assurance is responsible for the formulation, implementation and realization of the Company's global Quality strategy. The Vice President, Quality Assurance will: work with R&D, Clinical, Medical, Regulatory Affairs and Engineering on the company’s Quality strategy as a key input to product development; maximize on-time product approvals; manage strict regulatory practices globally within global standards of practice; maintain and protect the Company's existing product approvals; and develop and maintain high quality, productive relationships with statutory regulatory bodies globally.They will also serve as an expert related to the FD&C Act, 21CFR820, 210, 211, 212, 812, 807,  803 and 801 requirements. They will maintain ISO13485:2016-certified Quality Management System which is an integral part of achieving and maintaining required certifications and approvals, and ensures consistent, compliant operation of the company, in line with our Value of “Advancement: We have an unrelenting focus on quality.” The Vice President, Quality Assurance ensures that all of Sirtex's global Quality activities are undertaken in accordance with the highest ethical standards and in compliance with the laws, regulations, codes of conduct and other relevant guiding practices in the jurisdictions in which Sirtex and its subsidiary entities operate.NOTE: This position will be considered a hybrid position at a minimum, which is currently defined as 3 days/week in office and 2 days/week remote.  Primary Responsibilities:Lead the Quality Management System and Global QA team to ensure maintenance, improvement and development of the QMS in accordance with company values, policies, requirements & objectivesLead all QA audit programs (internal/external)Foster a collaborative approach to key company initiatives that advance the mission of Sirtex
