Working closely with executive leadership and senior functional leaders, the SVP Transformation establishes the roadmap, priorities, governance processes, and organizational capabilities necessary to support Medline's growth while ensuring alignment with FDA expectations and global regulatory requirements. This role provides strategic leadership, executive governance, and organizational oversight to ensure the company continues to strengthen regulatory compliance, quality system effectiveness, operational performance, risk management, and long-term business capabilities.

Job Summary

The Senior Vice President, Transformation is the executive leader responsible for developing and driving Medline's enterprise transformation strategy across quality, regulatory, compliance, operational, and business process functions.

This role provides strategic leadership, executive governance, and organizational oversight to ensure the company continues to strengthen regulatory compliance, quality system effectiveness, operational performance, risk management, and long-term business capabilities. Working closely with executive leadership and senior functional leaders, the SVP Transformation establishes the roadmap, priorities, governance processes, and organizational capabilities necessary to support Medline's growth while ensuring alignment with FDA expectations and global regulatory requirements.

The position serves as a key enterprise leader in advancing large-scale transformation initiatives, accelerating remediation efforts, strengthening quality and regulatory systems, and fostering a culture of continuous improvement, accountability, and excellence. Through leadership of senior leaders and cross-functional teams, the role ensures critical initiatives are appropriately prioritized, resourced, executed, and sustained to achieve strategic business objectives.

Job Description

MAJOR RESPONSIBILITIES

Strategic Transformation Leadership

• Lead large-scale enterprise transformation initiatives focused on quality system effectiveness, regulatory compliance, process maturity, risk management, operational performance, and sustainable business improvement.
• Establish transformation strategy, governance models, priorities, milestones, accountability structures, and success measures across Quality, Regulatory Affairs, Regulatory Compliance, Operations, and related functions.
• Partner with executive leadership to align transformation priorities with Medline’s business objectives, regulatory commitments, customer expectations, and growth priorities.
• Identify organizational, process, system, and capability gaps; develop practical, scalable solutions that support sustainable improvement and long-term operational effectiveness.

Quality, Regulatory & Compliance Transformation

• Provide executive oversight for initiatives designed to strengthen quality management systems, regulatory processes, documentation practices, inspection readiness, audit readiness, supplier oversight, and compliance governance.
• Work with functional leaders to ensure processes and procedures are designed, implemented, and maintained in alignment with FDA expectations, ISO requirements, EU MDR, and other applicable global regulatory standards.
• Drive improvement in supplier quality management, CAPA effectiveness, change control, risk management, validation, audit management, regulatory submissions support, and post-market compliance processes.
• Promote practical, scalable solutions that improve compliance, product quality, patient safety, operational efficiency, and business continuity.

Regulatory Compliance, Risk & Remediation

• Provide executive oversight for significant quality, regulatory, and compliance transformation programs, including remediation activities and regulatory commitments.
• Establish clear accountability, visibility, governance, escalation paths, and sustainability measures for remediation plans, deliverables, and enterprise risk priorities.
• Partner with Regulatory Affairs, Regulatory Compliance, Quality, Operations, Legal, and other stakeholders to ensure consistent execution of corrective actions, preventive measures, and risk mitigation plans.
• Review progress, remove barriers, and drive resolution of critical issues requiring executive intervention.

Cross-Functional Partnership & Executive Influence

• Work collaboratively with existing teams from a position of partnership, shared accountability, and practical support.
• Build strong relationships across Quality, Regulatory Affairs, Regulatory Compliance, Operations, Product Divisions, Supply Chain, Legal, Commercial, Engineering, and executive leadership.
• Provide coaching, guidance, and subject matter expertise to senior leaders and teams on regulatory expectations, quality systems, transformation methods, and process improvement.
• Communicate complex quality, regulatory, operational, and transformation matters clearly and effectively to executive stakeholders, business leaders, and cross-functional partners.

Continuous Improvement, Metrics & Business Impact

• Establish and monitor key performance indicators related to quality system health, regulatory compliance, audit readiness, remediation progress, supplier performance, process maturity, and risk reduction.
• Use data, analytics, and operational insights to identify trends, prioritize actions, measure transformation effectiveness, and inform executive decision-making.
• Promote innovation, technology enablement, and continuous improvement practices that improve quality, speed, efficiency, accountability, and business outcomes.
• Balance compliance requirements, operational efficiency, patient safety, customer expectations, and business priorities.

Executive Leadership & Talent Development

• Lead senior leaders, transformation teams, and cross-functional workstreams to execute strategic priorities and drive sustainable results.
• Foster a culture of accountability, collaboration, transparency, continuous improvement, and quality excellence.
• Build, mentor, and develop high-performing teams with the capabilities required to support enterprise transformation priorities.
• Provide resource planning, budget oversight, talent development, and performance leadership, as applicable, for transformation teams and workstreams.

 

MINIMUM JOB REQUIREMENTS

Education

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

Certification / Licensure

Professional quality, regulatory, or process improvement certification preferred, such as ASQ CQE, CQA, RAC, Lean Six Sigma, or equivalent.

Work Experience

At least 20 years of experience in Quality Assurance, Regulatory Affairs, Regulatory Compliance, Quality Engineering, Operations, or related functions within medical device, pharmaceutical, healthcare products, life sciences, or other highly regulated industries.

Demonstrated experience leading enterprise-wide transformation initiatives, remediation programs, regulatory compliance programs, or quality system modernization efforts.

Proven experience leading senior leaders, VP-level leaders, or large cross-functional teams in complex global organizations.

Experience supporting FDA inspections, notified body audits, regulatory agency interactions, and post-inspection remediation activities.

Demonstrated success strengthening quality management systems, supplier management programs, risk-based processes, CAPA systems, audit readiness, and compliance governance.

Experience leading large-scale initiatives across multiple sites, regions, and functions, including system transformations, site start-ups, regulatory approvals, and global process improvements.

Knowledge / Skills / Abilities

Deep knowledge of FDA Quality System Regulations, ISO 13485, EU MDR, and other applicable global regulatory requirements.

Strong understanding of regulatory affairs, regulatory compliance, quality systems, supplier quality, risk management, CAPA, audit management, validation, and inspection readiness.

Proven ability to develop and execute enterprise-level transformation strategies that balance compliance, operational efficiency, business needs, and patient safety.

Strong executive presence with the ability to influence senior leaders, regulatory stakeholders, customers, suppliers, and cross-functional partners.

Demonstrated ability to build practical, scalable quality and regulatory systems that work effectively in real-world operating environments.

Excellent communication, facilitation, stakeholder management, problem-solving, and decision-making skills.

Strong analytical capabilities and ability to use metrics, data, and governance processes to drive performance improvement.

Demonstrated success building high-performing teams, developing senior talent, and leading through influence and accountability.

Ability to operate effectively in a global, matrixed, fast-paced, and highly regulated environment.

Position requires travel up to 35–50% of the time for business purposes.

PREFERRED JOB REQUIREMENTS

Education

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

Certification / Licensure

ASQ Certified Quality Engineer, Certified Quality Auditor, Regulatory Affairs Certification, Lean Six Sigma, or equivalent certification preferred.

Work Experience

Experience leading FDA remediation efforts and enterprise regulatory transformation programs.

Experience overseeing or partnering closely with Regulatory Affairs and Regulatory Compliance functions.

Experience leading global quality, regulatory, or operational transformation across the U.S., Europe, APAC, and other international markets.

Experience supporting site start-ups, regulatory approvals, acquisition integrations, supplier transitions, and enterprise-wide system implementations.

Demonstrated experience leveraging technology, analytics, and process redesign to improve quality system maturity, speed, efficiency, and compliance outcomes.

Demonstrated examples of strategy development, deployment, and execution within complex global organizations.

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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

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.