Senior Director, Quality Assurance

Job Description

Job Description

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

SCOPE :

Primary focus of this role will be to lead the Quality function and Quality personnel in the execution of deliverables associated with new and existing products to meet global regulations and quality oversight at our facilities.

A creative and solution oriented individual with strong experience in development, mergers & acquisitions and global experience.

This role is located at the Sirtex Woburn facility.

PRIMARY RESPONSIBILITIES :

Responsible for ensuring compliance with all global regulations and Sirtex Quality Management System

Ensure that internal and external audits are adequately led by Quality and cross-functional personnel.

Ensure overall product quality requirements are met during development and at all manufacturing sites

Recruit, hire, and train Quality personnel

Ensure that environment and activities lead to attraction and retention, meeting business needs

Develop, maintain, monitor and improve Quality System related processes, tools, training, and metrics enabling Sirtex to meet business needs and comply and global regulations.

Observe and Comply with all Sirtex Corporate Policies

Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.

Qualifications

Bachelor’s degree required; BS in Engineering preferred

Minimum of 7 years of people management experience within medical device or pharmaceutical industry for global companies with multiple commercial products

Minimum of 12 years of experience within medical device or pharmaceutical industry for global companies with multiple commercial products

Demonstrated competency with the 21 CFR, 820, Medical Device Directive, EN ISO 13485, and EN ISO 14971

Demonstrated competency in ability to develop and implement strategy, people management, compliance and product quality achievement, mergers and acquisitions.

Knowledge of the EU MDR regulation

Strong communication, analytical and presentation skills. A team player that can roll up their sleeves as part of the larger organization to drive company culture

Competent in Microsoft Outlook, PowerPoint, Excel, Word, and Teams

Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross- functional environment

The target base salary range for this position will range from $226,000 to $275,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements.

Actual compensation may vary depending on the confirmed job-related skills and experience.

In addition to the expected base compensation, this role is eligible to participate in Sirtex’s incentive programs (target bonus of 25% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program .

Additional Information

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives.

Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates :

• 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.

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.