Acquisition Strategy, Analysis Skills, Best Practices, Biology, Biotech and Pharmaceutical, Business Administration, Business Performance Management, Coaching, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Customer Relations, Distribution Channel, Diversity, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Healthcare, ISO (International Organization for Standardization), International Operations, Leadership, Legal, Manufacturing, Medical Equipment, Mentoring, Operational Improvement, Operational Support, Operations Processes, Performance Metrics, Problem Solving Skills, Process Improvement, Product/Service Launch, Project Tracking, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Analysis, Risk Management, Sales/Support Engineering (SE), Startup, Strategic Planning, Supply Chain, Sustainability, System Operations, Team Lead/Manager, Trend Analysis, Vendor/Supplier Evaluation, Vendor/Supplier Quality Management, Vendor/Supplier Selection, Willing to Travel
Job Summary
Lead and accelerate strategic quality transformation initiatives across the enterprise to strengthen regulatory compliance, advance quality systems maturity, and support sustainable operational excellence.
This role serves as a hands-on quality transformation leader, partnering closely with Quality, Operations, Regulatory Affairs, and business leadership to enhance processes, strengthen supplier quality management systems, improve inspection readiness, and accelerate remediation efforts related to FDA and global regulatory requirements.
The VP, Quality Transformation will provide subject matter expertise, strategic guidance, and practical implementation support to existing teams, ensuring quality systems and processes are designed, executed, and maintained in alignment with regulatory expectations and industry best practices. The position is intended to drive meaningful progress on critical quality initiatives working side-by-side with existing teams, while fostering collaboration, capability building, and long-term sustainability.Job Description
MAJOR RESPONSIBILITIES
Quality Transformation Leadership
- Lead enterprise-wide quality transformation initiatives to strengthen compliance, quality systems effectiveness, operational performance, and risk management.
- Provide expert guidance on FDA regulations, quality system requirements, inspection readiness, remediation programs, and industry best practices.
- Evaluate current quality processes, systems, and organizational capabilities; identify opportunities to improve quality maturity and accelerate execution.
Regulatory Compliance & Remediation
- Provide oversight and direction for ongoing remediation activities to ensure alignment with FDA expectations and regulatory commitments.
- Assess compliance risks and partner with stakeholders to prioritize and execute corrective and preventive actions.
- Monitor progress of key remediation initiatives and ensure milestones, deliverables, and sustainability measures are achieved.
- Support preparation for regulatory inspections, audits, and agency interactions as required.
Quality Systems & Process Excellence
- Partner with Quality leadership to strengthen quality management systems, procedures, governance models, and controls.
- Drive improvements in supplier quality management, risk management processes, CAPA effectiveness, change management, and audit readiness.
- Implement scalable and practical quality solutions that balance compliance, operational efficiency, and business objectives.
- Advance proactive, risk-based approaches across global operations to improve product quality and regulatory outcomes.
Supplier Quality & Global Operations
- Strengthen supplier management systems and quality oversight programs across the global supply network.
- Partner with manufacturing, sourcing, distribution, and quality leaders to improve consistency, effectiveness, and accountability across sites.
- Support quality integration for new suppliers, product introductions, site start-ups, acquisitions, and other strategic initiatives.
Cross-Functional Partnership
- Work collaboratively with existing quality teams from a position of partnership, influence, and shared accountability.
- Provide coaching, mentoring, and expertise to leaders and teams on quality systems, regulatory expectations, and transformation best practices.
- Establish strong working relationships across Quality, Operations, Product, Regulatory, Supply Chain, Legal, and Commercial organizations.
- Facilitate alignment across stakeholders to ensure successful implementation of quality initiatives.
Continuous Improvement & Analytics
- Utilize data, metrics, and quality performance indicators to identify trends, prioritize actions, and measure effectiveness of transformation efforts.
- Lead large-scale process improvement initiatives that strengthen compliance while improving efficiency and business performance.
- Promote innovation and adoption of best practices to drive sustainable quality excellence.
Management Responsibility
- Lead cross-functional transformation teams and strategic initiatives designed to improve quality system effectiveness, regulatory compliance, supplier performance, and operational execution.
- Provide direction, coaching, and influence across multiple functions and levels of the organization, driving accountability and successful execution of key quality transformation objectives.
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 certifications (ASQ CQE, CQA, or equivalent) preferred.
Work Experience
At least 15 years of experience in Quality Assurance, Quality Engineering, Regulatory Affairs, or related functions within medical device, pharmaceutical, healthcare products, or other highly regulated industries.
Proven experience leading large-scale quality transformation initiatives, remediation programs, or quality system improvements.
Experience supporting FDA inspections, regulatory audits, and quality system compliance activities.
Demonstrated success implementing quality management systems, supplier quality programs, and risk-based quality processes.
Experience leading complex, cross-functional initiatives across multiple sites and global operations.
Knowledge / Skills / Abilities
Deep knowledge of FDA Quality System Regulations, ISO 13485, EU MDR, and other applicable global regulatory requirements.
Strong expertise in supplier quality management, CAPA systems, audit management, risk management, and quality system design.
Proven ability to lead transformation efforts while driving alignment and collaboration across existing organizations.
Excellent executive communication, influencing, facilitation, and stakeholder management skills.
Demonstrated experience building high-performing quality engineering and quality systems teams.
Strong analytical, problem-solving, and decision-making capabilities.
Ability to balance compliance, operational effectiveness, customer needs, and business objectives.
Position requires travel up to 35–50% for business purposes.
PREFERRED JOB REQUIREMENTS
Education
Master's degree in Engineering, Quality Management, Regulatory Affairs, Life Sciences, or MBA preferred.
Experience leading FDA remediation efforts and regulatory transformation programs.
Demonstrated success driving sustainable cultural and operational change within complex global organization.
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.