Vice President, Quality

Job Summary

The Vice President, Quality will be responsible for developing and leading a world-class quality organization, enabling the continued advancement of Terumo Medical Corporation’s medical device manufacturing and new product development.  This leader will be accountable for creating a scalable and sustainable quality organization aligned with the growth of the company and advancement of our portfolio.  The role will have responsibility for the end-to-end aspects of quality, including strategy development and implementation, quality compliance and systems, and validation for the organization and driving a culture of quality excellence within the organization.  Additionally, the role will be responsible for communicating directly with global regulatory agencies on behalf of Terumo Medical Corporation, including U.S. FDA, Health Canada, EU, ISO, Japan MHW, Brazil, Australia, etc. on global regulatory matters. The Vice President, Quality will collaborate closely with other Senior Staff Members to define the strategic direction of the organization and to drive business growth. 

Job Details/Responsibilities

Based on directives from both Company and government sources and policy, this position is responsible for the Quality and QS Compliance strategies for the Company.  As required, provides leadership and guidance to other Terumo facilities.

• This position is executive management with Quality System management responsibilities per the FDA and international regulations.  Quality System management responsibilities include, but are not limited to, the following: assuring the suitability and effectiveness of the quality system; appointment of an appropriate Management Representative; providing adequate resources and organization structure with defined responsibilities and authorities; ensuring that the quality policy is understood, implemented, and maintained at all levels of the organization; participating in management review, quality planning and establishing adequate quality system procedures.
• Develop and execute a comprehensive quality strategy that aligns with the company’s objectives.
• Provide strategic leadership to the quality organization, ensuring the team is equipped to succeed.
• Continuously improve and optimize quality systems to enhance efficiency and effectiveness.
• Define and monitor KPI’s for quality and compliance.
•  Maintain professional relationships with regulatory agencies and industry groups, especially in the company’s product lines, to identify current and future business opportunities and emerging medical and health care practices. 
• Direct the assigned Quality Management System activities, Adverse Event reporting, root-cause investigation, and resolution.
• Directs changes in company policy to ensure product safety and effectiveness, ethical behavior, and compliance with requirements.
• Support activities related to the Products Liability policy including annual renewal, notification of insurance claims / legal action, investigation of related events and participation in the Risk Management Committee.
• Assure corporate compliance and maintain processes to enhance corporate integrity, encourage ethical behavior, optimize quality, cycle-time efficiency, productivity, manufacturing cost and Terumo’s business performance.
• Assist management of other regulated processes including occupational safety, environmental protection, labor laws, transportation regulations, Sales/Marketing activities.
•   Performs the duties of the Person Responsible for Regulatory Compliance per    EU MDR 2017/745.  
• Performs other job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Must be able to address regulatory questions from FDA investigators and Notified Body auditors by successfully communicating the company’s methods of compliance with the applicable regulations and standards. 
• Incumbent must maintain up-to-date knowledge of all applicable regulations, guidelines, and regulated industry trends.  
• Proven ability to communicate effectively and work collaboratively with senior management at the Notified Bodies, Competent Authorities and/or select governmental representatives.
• Independent decision-making is expected for all routine business issues including interactions with the FDA, Notified Body, customers, etc. while being guided by Terumo’s mission and strategic plan.
• Develop trust and earn respect across organization.   
• Experience in leading an organization through ambiguous situations.
• Shown managerial courage.
• Must be able to assess the level of compliance in each area.
• Demonstrated track record of developing talent to meet their individual career goals, as well as the organization’s goals.
• Good working knowledge of the device development process, device laws, regulations, and guidelines.  
• Excellent analytical skills and problem-solving ability.  
• Excellent oral and written communication skills including the ability to discuss scientific/technical data and regulatory requirements with senior management and Notified Bodies, Competent Authorities and/or select governmental representatives.
   

Qualifications/ Background Experiences

• Position requires a 4-year degree in engineering or scientific discipline; an advanced degree is preferred.  
• Minimum of 4 years of experience in medical device quality is required.   
• Minimum 15 years in a regulated industry with 5 or more years in a leadership role is required.  
• Significant experience with quality systems, engineering design controls, sterilization, bio-safety testing of materials, controlled environments, clinical use of medical devices is also required. 
• Successful experience involving endovascular devices is a plus.