VP Distribution Quality

Medline; Northfield Township (IL); On-site; USD 180,000 - 230,000; Full time

Job summary

Medline in the United States seeks an executive leader to drive distribution quality governance and ensure product integrity across storage, transport, and hold management, from manufacturing release to final delivery.

The role partners with Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership to set strategy, governance, and capability, ensuring timely escalation and sustainable regulatory compliance across the network.

Qualifications

• Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or related field.
• Professional quality or regulatory certification preferred.
• 12+ years of progressively responsible experience in Quality Assurance, Regulatory Affairs, Quality Engineering, or related function in a highly regulated industry.
• 7+ years of people-leadership experience across multiple sites/regions.
• Experience establishing functional strategy, leading cross-functional initiatives, and delivering sustained quality or regulatory outcomes.

Responsibilities

• Set strategy, governance, and accountability for distribution quality across the network.
• Own ship hold management, including placement, review, escalation, disposition, and release of product holds.
• Ensure distribution deviations, nonconformances, investigations, and corrective actions are timely and effective.
• Direct quality oversight of warehouses and third-party logistics providers, including qualification, quality agreements, monitoring, and escalation.
• Own distribution-only quality programs for products sourced and distributed without internal manufacturing involvement.
• Direct storage, temperature control, and cold chain programs to ensure products remain within validated conditions.
• Lead and develop regional distribution quality leaders and teams, ensuring consistent standards and capability across the network.
• Partner with Supply Chain, Operations, Regulatory Affairs, Product Quality, Supplier Quality, and Commercial teams on distribution risks and customer needs.
• Use quality metrics and trend data to identify risk, improve performance, and sustain product integrity through delivery.
• Lead, organize, plan, direct, staff, coordinate, and communicate across leaders and teams responsible for the function to execute business plans and required organizational changes.
• Set performance standards, establish clear decision rights and accountability, monitor performance, develop talent, and maintain appropriate staffing and capabilities.
• Build an environment of open communication, collaboration, disciplined execution, and continuous improvement.

Skills

Quality leadership

Regulatory compliance

Cross-functional leadership

Risk management

Executive communication

Analytical skills

Education

Bachelor's degree in Engineering/Quality Assurance/Life Sciences/Reg regulatory Affairs/Business

Job description

Job Summary

Provide executive leadership for distribution and commercial quality, ensuring product integrity, compliant storage and transportation, effective hold controls, and consistent quality oversight from manufacturing release through final delivery to customers.

Provide executive leadership for distribution and commercial quality, ensuring product integrity, compliant storage and transportation, effective hold controls, and consistent quality oversight from manufacturing release through final delivery to customers.

The role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. The leader is accountable for effective execution, timely escalation, and sustainable compliance with applicable requirements.

The role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. The leader is accountable for effective execution, timely escalation, and sustainable compliance with applicable requirements.

MAJOR RESPONSIBILITIES

Distribution Quality Governance

Set strategy, standards, governance, and accountability for distribution quality across the network.

Own ship hold management, including placement, review, escalation, disposition, and release of product holds.

Ensure distribution deviations, nonconformances, investigations, and corrective actions are timely and effective.

Warehouse, 3PL & Product Controls

Direct quality oversight of warehouses and third-party logistics providers, including qualification, quality agreements, monitoring, and escalation.

Own distribution-only quality programs for products sourced and distributed without internal manufacturing involvement.

Direct storage, temperature control, and cold chain programs to ensure products remain within validated conditions.

Network Leadership & Partnership

Lead and develop regional distribution quality leaders and teams, ensuring consistent standards and capability across the network.

Partner with Supply Chain, Operations, Regulatory Affairs, Product Quality, Supplier Quality, and Commercial teams on distribution risks and customer needs.

Use quality metrics and trend data to identify risk, improve performance, and sustain product integrity through delivery.

Management Responsibility

Lead, organize, plan, direct, staff, coordinate, and communicate across leaders and teams responsible for the function to execute business plans and required organizational changes.

Set performance standards, establish clear decision rights and accountability, monitor performance, develop talent, and maintain appropriate staffing and capabilities.

Build an environment of open communication, collaboration, disciplined execution, and continuous improvement.

MINIMUM JOB REQUIREMENTS

Education

Typically requires a Bachelor's degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or a related field.

Certification / Licensure

Professional quality or regulatory certification preferred, as applicable to the function.

Work Experience

At least 12 years of progressively responsible experience in Quality Assurance, Regulatory Affairs, Quality Engineering, or a related function within medical device, pharmaceutical, healthcare products, or another highly regulated industry.

At least 7 years of people-leadership experience, including leading leaders and teams across multiple sites, regions, products, or disciplines.

Demonstrated experience establishing functional strategy, leading complex cross-functional initiatives, and delivering sustained quality or regulatory outcomes.

Knowledge / Skills / Abilities

Strong knowledge of applicable FDA requirements, ISO 13485, EU MDR, and other global quality and regulatory requirements relevant to the function.

Proven ability to translate regulatory and quality requirements into practical, scalable operating processes and controls.

Strong leadership, organizational design, talent development, and performance management capabilities.

Excellent executive communication, influencing, facilitation, and stakeholder management skills.

Strong analytical, risk-management, investigation, problem-solving, and decision-making capabilities.

Ability to balance compliance, product quality, patient safety, customer needs, and business objectives.

Position requires travel up to 35-50% for business purposes, including domestic and international travel.

PREFERRED JOB REQUIREMENTS

Master's degree in Engineering, Quality Management, Regulatory Affairs, Life Sciences, or Business preferred.

Relevant professional certification and experience i