Driving the future of supplier audits and site risk management in Healthcare and Life Sciences
At Qualifyze, we believe supplier audits and site risk management should be proactive, not reactive.
Our mission is to empower Healthcare and Life Sciences companies with AI-driven insights, streamlined audits, and predictive compliance oversight, enabling faster, smarter, and more strategic supplier decisions.
Our story
We started with a simple but powerful idea:
quality compliance shouldn’t be a bottleneck.
It should be a driver of better risk management.
The industry was burdened by manual audits, scattered data, and limited visibility into supplier site risks.
We built Qualifyze to transform compliance from a regulatory task into a strategic advantage, giving Life Sciences leaders the power to make informed, data-driven decisions with confidence.
Why Qualifyze?
Specialized in Life Sciences compliance
Specialized in Life Sciences compliance
Deep industry expertise in GxP audits, regulatory requirements, and supplier site risk management.
AI-driven insights for smarter decisions
AI-driven insights for smarter decisions
Our technology turns unstructured audit data into predictive risk intelligence, helping teams act before issues escalate.
Scalable, flexible audit solutions
Scalable, flexible audit solutions
From rapid supplier qualification to fully digitized audit workflows, we help companies of all sizes reduce costs, improve efficiency, and enhance compliance visibility.
Our impact
Ready-to-use audit reports powering supplier decisions worldwide
0
+
New audits added monthly for faster, cost-effective supplier qualification
0
+
Trusted Life Sciences companies worldwide
0
+
Meet our Senior Advisors
Michael Rogers
Former Associate Commissioner for Inspections and Investigations. U.S. FDA
With over 30 years of leadership at the U.S. FDA, Michael C. Rogers most recently served as Associate Commissioner for Inspections and Investigations, overseeing the agency’s global inspectorate of more than 4,000 professionals.
His responsibilities spanned criminal investigations, import operations, and emergency response.
He played a key role in leading the FDA’s largest reorganization and has testified before Congress on critical public health issues.
Earlier in his career, Michael directed food safety operations across 1,100+ staff and served as Regional Director for Latin America, managing FDA offices in Mexico, Costa Rica, and Chile, and leading regulatory efforts across 44 countries.
He began his career as a field investigator conducting domestic and foreign inspections in a variety of program areas.
He holds a Master’s Degree in Science of Management from the University of Maryland and a Bachelor’s Degree from North Carolina State University, and maintains Top Secret security clearance, reflecting decades of trusted service at the highest level.
His responsibilities spanned criminal investigations, import operations, and emergency response.
He played a key role in leading the FDA’s largest reorganization and has testified before Congress on critical public health issues.
Earlier in his career, Michael directed food safety operations across 1,100+ staff and served as Regional Director for Latin America, managing FDA offices in Mexico, Costa Rica, and Chile, and leading regulatory efforts across 44 countries.
He began his career as a field investigator conducting domestic and foreign inspections in a variety of program areas.
He holds a Master’s Degree in Science of Management from the University of Maryland and a Bachelor’s Degree from North Carolina State University, and maintains Top Secret security clearance, reflecting decades of trusted service at the highest level.
Juan Torres
Previously Chief Quality Officer at Biogen
Dr. Juan Torres is a NIIMBL Senior Fellow and President of Ingenuitas, a non-profit organization dedicated to advancing innovative health solutions for underserved communities and STEM education.
With over 30 years of leadership experience in the biotechnology and pharmaceutical sectors, he specializes in quality systems innovation, biopharmaceutical development, and regulatory compliance.
Previously, Juan served as Chief Quality Officer at Biogen for almost two decades.
He has also held Quality executive positions at Bayer and J&J.
He now leads Futurum Biosciences, a consultancy focused on enhancing biotech quality processes.
Known for his integrity, global perspective, and commitment to mentorship, Juan continues to make significant contributions to the advancement of biotechnology.
He holds PhD degrees in Biochemistry and Toxicology, as well as postdoctoral experience in Chemical Engineering from North Carolina State University.
With over 30 years of leadership experience in the biotechnology and pharmaceutical sectors, he specializes in quality systems innovation, biopharmaceutical development, and regulatory compliance.
Previously, Juan served as Chief Quality Officer at Biogen for almost two decades.
He has also held Quality executive positions at Bayer and J&J.
He now leads Futurum Biosciences, a consultancy focused on enhancing biotech quality processes.
Known for his integrity, global perspective, and commitment to mentorship, Juan continues to make significant contributions to the advancement of biotechnology.
He holds PhD degrees in Biochemistry and Toxicology, as well as postdoctoral experience in Chemical Engineering from North Carolina State University.
Filip De Keersmaecker
Served as VP Global MedTech Supply Chain, Johnson & Johnson
Filip De Keersmaecker is a highly experienced global supply chain leader with over 25 years of expertise in managing complex end-to-end operations across various industries, including healthcare, pharmaceuticals, and consumer goods.
He currently serves as a Senior Advisor at McKinsey & Company, where he provides strategic guidance to leading organizations on supply chain and operational excellence.
Previously, Filip held senior leadership positions at Johnson & Johnson, where he successfully led the MedTech Supply Chain, driving key initiatives in global planning, demand and supply performance, and product lifecycle management.
He played a pivotal role in the company's COVID-19 response, improving supply chain metrics and ensuring product availability in critical markets.
Filip's strategic leadership has enabled significant growth, cost savings, and operational efficiencies throughout his career, making him a trusted advisor to CEOs and boards worldwide.
He currently serves as a Senior Advisor at McKinsey & Company, where he provides strategic guidance to leading organizations on supply chain and operational excellence.
Previously, Filip held senior leadership positions at Johnson & Johnson, where he successfully led the MedTech Supply Chain, driving key initiatives in global planning, demand and supply performance, and product lifecycle management.
He played a pivotal role in the company's COVID-19 response, improving supply chain metrics and ensuring product availability in critical markets.
Filip's strategic leadership has enabled significant growth, cost savings, and operational efficiencies throughout his career, making him a trusted advisor to CEOs and boards worldwide.
Steve Van Kuiken
Senior Partner Emeritus at McKinsey & Company
Steve Van Kuiken is a seasoned technology and healthcare advisor with extensive experience driving large-scale, tech-enabled transformations across industries.
He currently serves as a board member for two technology companies and a biotech startup, and advises early-stage technology ventures on go-to-market strategy, market fit, and operational efficiency.
During his tenure at McKinsey & Company, Steve founded and led McKinsey Technology, the firm’s global enterprise technology practice.
In this role, he spearheaded the strategic alliance with AWS and led the acquisition of Candid Partners, laying the foundation for McKinsey’s Cloud consulting capabilities.
He previously led the North American Digital Practice and founded McKinsey’s global Healthcare Technology Practice.
Much of Steve’s work at McKinsey focused on helping large organizations—particularly in Pharma, MedTech, and Payor sectors—achieve performance breakthroughs through technology-enabled transformation.
His strategic leadership and deep domain expertise continue to make him a trusted advisor to technology innovators and industry leaders alike.
He currently serves as a board member for two technology companies and a biotech startup, and advises early-stage technology ventures on go-to-market strategy, market fit, and operational efficiency.
During his tenure at McKinsey & Company, Steve founded and led McKinsey Technology, the firm’s global enterprise technology practice.
In this role, he spearheaded the strategic alliance with AWS and led the acquisition of Candid Partners, laying the foundation for McKinsey’s Cloud consulting capabilities.
He previously led the North American Digital Practice and founded McKinsey’s global Healthcare Technology Practice.
Much of Steve’s work at McKinsey focused on helping large organizations—particularly in Pharma, MedTech, and Payor sectors—achieve performance breakthroughs through technology-enabled transformation.
His strategic leadership and deep domain expertise continue to make him a trusted advisor to technology innovators and industry leaders alike.