Director, Global Quality & Compliance

Terumo BCT, Inc. • Denver, CO

3d • $199,600 - $249,500 • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• Advanced degree such as MS, MBA, or PhD
• Six Sigma Black Belt or Master Black Belt certification

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Participates as a member of the Quality Leadership team.

Benefits

• Multiple group medical, dental and vision plans
• Robust wellness program
• Life insurance and disability coverages
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
• 401(k) plan with a matching contribution
• Vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director