Vice President, Quality Assurance (Boston, MA)

Company Description

Who we are…

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast-growing dynamic organization and we seek an experienced VP, Quality Assurance to help us with our growth. This position is located in our Woburn MA HQ.

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions.

Here, you will be a vital contributor to our inspiring and bold mission.

Job Description

The VP, QA holds a pivotal role in driving the Quality Assurance function at Sirtex Medical Pty Ltd and its subsidiary entities. This position encompasses all Quality-related activities and personnel on a global scale, spanning current and future product lines. The VP, QA also serves as a vital member of the Sirtex Leadership Team.

The VP, QA position is based at the Sirtex facility in Woburn, MA. Strong preference for candidates currently residing in Boston, MA area.

• Lead the development, implementation, and realization of the global Quality Strategy to align with and advance business objectives.
• Manage a globally dispersed QA team, promoting inclusivity and diversity in recruitment, and ensure the Quality Management System adheres to global medical device and pharmaceutical regulations.
• Direct QA budget development while maintaining costs within budget constraints.
• Build and maintain strong relationships with internal and external stakeholders, valuing diverse perspectives and fostering inclusive collaboration.
• Interact with external regulatory agencies with an inclusive mindset, leading to successful outcomes that reflect regulatory compliance.
• Ensure product quality and compliance with applicable medical device and pharmaceutical regulations.
• Foster a culture of diversity and inclusion within the global Quality Assurance team, ensuring that diverse perspectives and voices are valued and integrated into quality strategies.

Qualifications

• Bachelor's degree in a relevant field (engineering, science, etc.)
• A minimum of 15 years of Quality experience with multi-national medical device company.  Combination product experience is highly preferred.  
• A minimum of 7 years of senior management Quality experience in a global role with multi-national pharmaceutical and/or medical device companies with a minimum annual revenue of $1bn.  Device experience is a must.  Experience with both small and large organizations highly desired.
• Must have PMA, remediation and integration experience.
• Demonstrated expertise in developing, implementing, and measuring Quality Management Systems that prioritize inclusivity and comply with applicable global medical device or pharmaceutical regulations.
• A proven track record of successfully achieving and maintaining compliance with global medical device or pharmaceutical regulations while achieving business objectives.
• Demonstrated competency in developing and implementing global Quality strategies and effective cost management practices.
• Willingness to participate in meetings spanning multiple global time zones and undertake a minimum of 25% travel, with an inclusive approach to accommodating diverse team members' needs.
• Excellent communication, presentation, and influencing skills.

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 p