Sr. Clinical Quality Specialist
Somerset, NJ, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Sr. Clinical Quality Specialist is responsible for leading and executing clinical quality oversight activities across Terumo’s clinical trials. This role ensures compliance with study protocols, of ISO 14155 / 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes.
Key responsibilities include planning and conducting audits, managing vendor quality performance, leading risk mitigation strategies, and serving as a subject matter expert for inspection readiness. The Sr. Clinical Quality Specialist collaborates cross-functionally to resolve complex quality issues, develop quality metrics and dashboards, and support the creation of training programs and controlled documents. This role operates with a high degree of independence and provides strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety throughout the study lifecycle.
Job Details/Responsibilities
Leading the development and execution of Clinical Risk Management Plans and Clinical Quality Plans for studies
Conducting audits of clinical sites and eTMF to ensure compliance with ICH-GCP and internal procedures. Track and manage Audit Deficiency Records, ensuring timely approval and effectiveness verification.
Developing and reporting of Clinical Quality Metrics and KPIs across studies
Performing vendor management, including audits and issue escalation for clinical suppliers
Advising clinical teams on handling noncompliance and quality issues during study execution
Collaborating with stakeholders to lead revisions of processes and documents within the change control process for new/revised regulatory standards impacting clinical.
Developing training and tools for inspection readiness as well as supporting external inspections.
Knowledge, Skills and Abilities (KSA)
• Deep understanding of ISO 14155 / 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations
• Strong auditing and risk management skills. Prior experience with auditing and risk management.
• Proficient in EDC and CTMS systems (e.g.,Veeva), MS Office tools.
• Excellent time management, prioritization, communication, negotiation, and problem-solving abilities
• Ability to analyze and present quality metrics and KPIs
• Ability to manage projects and process improvement initiatives
• Understanding of Clinical Monitoring, IRBs, and Safety oversight
• Exhibits adaptability and takes initiative in supporting departmental projects and initiatives, contributing effectively during and between studies, as required.
Qualifications/ Background Experiences
• Bachelor’s degree in life sciences, nursing, or related field required and minimum 5 years of experience in clinical quality assurance or clinical quality operations or a combination of relevant experience, training, and education.
• Experience conducting audits and managing clinical vendors required.
• Certification in auditing or clinical research (e.g., CQA, RQAP-GCP, CCRA) required.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range: $87,800 - $109,700
Nearest Major Market: New Jersey