Vice President, Quality Assurance

Sirtex Medical Limited; Woburn (MA); Hybrid; USD 241,000 - 270,000; Full time

Benefits offered by this job

Flexible work arrangements

Professional development opportunities

Attractive compensation package

Job summary

A leading medical technology firm is seeking a Vice President of Quality Assurance in Woburn, Massachusetts. This executive role involves overseeing the Quality Assurance function for medical devices and pharmaceuticals. Candidates should possess a Bachelor's degree, extensive industry experience, and proven capability in regulatory affairs. The position offers a hybrid work environment and a competitive salary range of $241,000 to $270,000 annually.

Qualifications

• Minimum 10 years of industry experience in pharmaceutical and medical technology environments.
• Experience in obtaining FDA approval for therapies is mandatory.
• Demonstrated ability to lead teams and develop people.

Responsibilities

• Lead the Quality Management System and Global QA team.
• Manage QA audit programs and ensure compliance.
• Foster collaboration for key company initiatives.

Skills

Leadership

Communication

Regulatory Compliance

Education

Bachelor's degree in Medicine, Health Sciences, Law, or Engineering

Post-graduate degree in Regulatory Affairs

Job description

Overview

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.

Working arrangements

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

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 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, 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, defined as 3 days/week in office and 2 days/week remote.

Key responsibilities

1. 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


2. Lead all QA audit programs (internal/external)


3. Foster a collaborative approach to key company initiatives that advance the mission of Sirtex

Qualifications

• 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

Compensation

The base salary range for this position is $241,000 to $270,000 annually. Individual compensation will be based on non-discriminatory factors, including geographic location, skills, experience, and education. Actual compensation may vary based on job-related skills and experience. This role is eligible to participate in Sirtex’s incentive programs (target bonus of 25%).

Benefits and Additional Information

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.


• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.


• Attractive compensation and benefit packages which are practical, robust and equitable.


• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.


• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.


• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Equal Opportunity

Sirtex is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Seniority level

Executive

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing