Vice President, Quality Assurance

Company Description

Sirtex Medical 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 aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing 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, all while delivering innovative healthcare solutions to patients.

Job Description

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.  Candidates must live in the Boston, MA area or be willing to relocate to the area.

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 & objectives
• Lead all QA audit programs (internal/external)
• Foster a collaborative approach to key company initiatives that advance the mission of Sirtex

Qualifications

• Minimum of a Bachelor's degree 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