Job Summary
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.
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 requirement
Job Description
JOB SUMMARY
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.
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
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
Minimum 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 in a complex global healthcare products organization preferred.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$234,000.00 - $351,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.