
Qualis Business Consulting LLC
Navigating Complexity, Applying Judgement,
& Delivering Solutions

Precision Consulting

Optimizing Operations for Global Quality Leaders
Qualis Business Consulting delivers specialized insights and strategic support tailored for the pharmaceutical and medical device industries, driving growth through Quality and Operational precision.
email: contact-us@qualisbusinessconsulting.com
Call us: (949) 990-8133
Specialized Strategy & Operational Consulting Services

We provide medical device and pharmaceutical enterprises with advice in strategy, facilitating operational excellence projects, and creating value across the life sciences landscape.

Operational Workflow Optimization
Redefining manufacturing protocols and workflow efficiency through technical analysis and lean methodologies tailored for sterile pharmaceutical environments.

Quality & Regulatory Strategy
Navigating the complex landscape of the international pharmaceuticals and medical device regulations to ensure rapid lifecycle compliance and market readiness.

Supply Chain Resilience
Constructing robust distribution networks that withstand global volatility, ensuring the clinical availability of critical pharmaceutical supplies.
Compliance Services
Proactive Quality, Manufacturing, and Compliance Planning & Training Services
Remediation Planning and Execution Management
Quality Culture Maturity Assessments &
Improvement Planning
Contact us to organize service.
Landon G. Piluso, Ph.D.
Dr. Landon G. Piluso is a pharmaceutical and medical device executive, quality leader, and author with more than three decades of experience spanning the pharmaceutical, biotechnology, combination product, and medical device sectors. His career has encompassed positions of increasing technical, operational, and executive responsibility within research and development organizations, quality functions, and commercial manufacturing operations. His expertise includes small-molecule pharmaceuticals, biologics, therapeutic combination products, and Class I, II, and III medical devices.
Throughout his professional career, Dr. Piluso has held senior leadership roles across a range of globally recognized healthcare organizations. He previously served as Director of Global Quality and Corporate Process Owner for Therapeutics Lifecycle Management at Baxter Healthcare, where he was responsible for advancing quality systems and lifecycle management strategies across the organization. During his tenure at Baxter, he also held multiple operations leadership positions at four manufacturing facilities, developing extensive expertise in manufacturing operations, quality systems, and operational excellence. In addition, he has held technical and leadership positions in quality and operations at the City of Hope National Medical Center, Medtronic, and Gilead Sciences.
As Global Head of Quality for the PolyPeptide Group, Dr. Piluso provided strategic leadership for quality and compliance activities across six international manufacturing sites located in Belgium, France, India, Sweden, and the United States. In this role, he was responsible for ensuring the consistent implementation of global quality standards and regulatory expectations across a diverse and geographically distributed manufacturing network.
Complementing his industry leadership experience, Dr. Piluso has authored numerous scientific publications in both academic and industrial settings, contributing to the advancement of knowledge across a broad range of scientific, technical, quality, and operational disciplines.
Dr. Piluso works as the Founder of Qualis Business Consulting LLC, where he advises pharmaceutical and medical device organizations on quality management systems, regulatory compliance, operational excellence, lifecycle management, and strategic quality initiatives. His work reflects a commitment to integrating scientific rigor, regulatory insight, and practical industry experience to support the development, manufacture, and delivery of safe and effective healthcare products which improve the lives of patients worldwide.
