Hiring: Director, Global Quality & Compliance Company: Terumo Blood and Cell Technologies Location: Lakewood, CO Job Posted Time: 2026-09-10 13:44:15 Employment Type: Hybrid Target Skills & Keywords : Change Management, Digital Transformation, Project Management, Quality Assurance, R, Regulatory Compliance, Risk Management, Six Sigma About the job Experience: •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. •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. Required Skills: •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. •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. Qualifications: •Bachelor’s degree in engineering, life sciences, or a related field required; advanced degree such as MS, MBA, or PhD strongly preferred. •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. •Typical office environment requirements include reading, speaking, hearing, close vision, traversing, bending, sitting, and occasional lifting up to 20 pounds. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!