Director, Global Quality & Compliance
Listed on 2026-08-22
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
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Director, Global Quality & ComplianceDate: Aug 19, 2026
Location: Lakewood, CO, US
Requisition : 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.
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.
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,
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