Senior Director, 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

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

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