Requisition ID:  35415  

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

JOB SUMMARY

The Director, Global Quality & Compliance is responsible for developing, implementing, maintaining, and continuously improving global quality management systems, standards, and governance across all areas of quality. This role ensures global quality processes are effective, harmonized, scalable, and compliant with applicable regulatory requirements, international standards, and industry best practices. The position provides strategic leadership for global quality assurance, regulatory compliance, inspection readiness, validation, laboratory controls, post-market compliance, and continuous improvement initiatives that support customer, patient, and regulatory expectations. This leader also drives adoption of digital transformation efforts that strengthen quality system performance, data integrity, compliance oversight, and operational efficiency. Collaborating closely with R&D, Operations, Commercial teams, Regulatory Affairs, and Quality functions, this leader oversees critical projects in alignment with key business initiatives. This role reports directly to the VP of Global Quality.

ESSENTIAL DUTIES

Quality Assurance

• Lead the global Quality Assurance organization to develop, implement, govern, and continuously improve global quality management systems and standards across all areas of quality management in compliance with FDA QMSR, ISO 13485, EU MDR, and other applicable international requirements.
• Maintain accountability for the design, implementation, effectiveness, harmonization, and continuous improvement of core global quality processes, including document control, nonconformance, CAPA, internal audit, management review, validation, laboratory controls,  post-market compliance, and other globally standardized quality system processes.
• Drive adoption of digital transformation initiatives within the global quality organization, including validated digital systems, quality data analytics, automation, and standardized tools that improve compliance oversight, process efficiency, visibility, and evidence-based decision-making.
• Provide leadership and oversight for post-market compliance, including complaint handling, adverse event reporting, medical safety evaluations, post-market surveillance, quality signal escalation, field action support, and implementation of related process improvements.
• Provide leadership and oversight of global validation activities, including validation strategy, risk assessments, protocol development, execution oversight, cross-functional alignment for business-critical initiatives, and implementation of related process improvements.
• Provide leadership and oversight of global internal audit and inspection readiness activities, including oversight of internal and due diligence audits, timely resolution of audit findings, preparation for regulatory inspections, maintenance of applicable notified body and quality system certifications, and implementation of related process improvements.

Regulatory Compliance

• Ensure global quality processes remain aligned with applicable regulatory requirements, including FDA, EMA, ISO, and country-specific standards.
• Proactively monitor regulatory and industry changes and implement updates to global quality policies, procedures, standards, and governance practices.
• Represent the company during regulatory inspections and audits, achieving favorable outcomes and resolving findings efficiently.

Leadership and Strategy

• Define and execute a global quality and compliance strategy that strengthens quality system maturity, supports business goals, enables digital transformation, and promotes consistent execution across regions and functions.
• Build and inspire high-performing quality teams across regions, fostering a culture of excellence and compliance.

• Partner with cross-functional teams (e.g., R&D, manufacturing, supply chain, clinical) to ensure quality is integrated throughout the product lifecycle.

Risk Management and Continuous Improvement

• Identify and mitigate quality and compliance risks through proactive monitoring and intervention.

• Drive a culture of continuous improvement by implementing quality metrics, analyzing performance trends, using digital and data-enabled insights, and leading initiatives that optimize quality system effectiveness and process performance.

• Lead root cause investigations for quality issues and implement corrective and preventive actions.

OTHER DUTIES AND RESPONSIBILITIES

• Participates as a member of the Quality Leadership team.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in engineering, life sciences, or a related field required; advanced degree such as MS, MBA, or PhD strongly preferred.

• Minimum 10 years of progressive experience in quality assurance, quality systems, manufacturing, or regulatory compliance within a regulated industry, such as medical devices, pharmaceuticals, biotechnology, or combination products.

• Strong knowledge of international regulatory requirements, including FDA QMSR, ISO 13485, EU MDR/IVDR, and applicable country-specific regulations as applicable to medical devices, drug manufacturing and/or combination products.

• Demonstrated experience supporting regulatory inspections, audits, certifications, and related inspection readiness activities.
• Demonstrated leadership experience managing global teams and complex quality initiatives.
• Six Sigma Black Belt or Master Black Belt certification preferred.

Skills

• Exceptional analytical, problem-solving, and decision-making skills, particularly in high-pressure environments.
• Outstanding interpersonal and communication skills, with the ability to engage effectively with cross-functional stakeholders and external regulators.
• Expertise in quality management software, tools, and data analytics to support decision-making.

• Demonstrated knowledge of manufacturing operations, process and computer systems validation, engineering, tactical execution, customer service, professional communications, cross-functional collaboration, computer applications, problem solving, strategic reasoning, teamwork, change management, business acumen, and business ethics.
• Demonstrated expertise in planning, budgeting, and project management toward achievement of annual, long-term, and strategic business objectives.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical office environment requirements include reading, speaking, hearing, close vision, traversing, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

There will be an occasional requirement to work outside of normal business hours, consistent with other manufacturing positions.

U.S. and international travel may be required up to 40%.

Target Pay Range:  $199,600.00 to $249,500.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  30.0%

We anticipate this requisition will be open for a minimum of five (5) days, from 8/19/2026. We encourage your prompt application.

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.