Vice President, Quality Assurance

Sirtex Medical Limited is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we provide innovative products that enhance patient outcomes and simplify treatments. Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.

We have delivered over 150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by a dedication to the medical community, professionalism, collaboration, entrepreneurship, and ongoing pursuit of innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, delivering innovative healthcare solutions to patients.

Note:

This position will be considered hybrid, defined as 3 days per week in office and 2 days remote.

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 devices 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, 21

CFR
820, 210, 211, 212, 812, 807, 803 and 801 requirements. They will maintain ISO
13485:2016-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, defined as 3 days/week in office and 2 days/week remote.

• Minimum of a Bachelor s degree in Medicine, Health Sciences, Law, Engineering or other relevant tertiary degree is required
• Further post-graduate degree in Regulatory Affairs, e.g. Masters of Regulatory Science or post-graduate commercial degree, e.g. MBA is desirable
• Minimum 10 years industry experience in a multi-national pharmaceutical AND medical technology environments is mandatory
• Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory
• Prior experience in leading successful CE submissions to EU Notified Bodies is desired
• Prior experience within a national regulatory agency US FDA, EMA, Australian TGA is desirable
• Extensive experience in people leadership and development
• Excellent communication, presentation and influencing skills
• Willingness and ability to work within cross-functional teams of internal peers and multi-disciplinary teams including external thought leader
• Travel approximately 15% with some international travel required

The base salary range for this position is $241,000 to $270,000 annually. Individual compensation will be based on…