Nancy Duarte-Lonnroth
Vice President Of Quality
Professional Overview
Nancy Duarte-Lonnroth is an accomplished quality assurance and regulatory affairs leader with over 25 years of experience in the pharmaceutical and medical device industries. As the Vice President of Quality at Praxis Precision Medicines, Inc., she is responsible for overseeing the company's quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
Experience Summary
Current Role
As the Vice President of Quality at Praxis Precision Medicines, Inc. since 2020, Nancy is responsible for establishing and maintaining robust quality systems, implementing quality control measures, and leading a team of quality assurance professionals. She has played a pivotal role in ensuring the company's compliance with GxP regulations and industry best practices, contributing to the successful development and commercialization of the organization's therapeutics.
Career Progression
Prior to her current role, Nancy served as the Vice President of Quality at Acer Therapeutics Inc., where she was instrumental in strengthening the company's quality management systems and guiding the organization through regulatory inspections. She has also held senior quality and regulatory affairs roles at various pharmaceutical and medical device companies, including International Partnership for Microbicides, AMAG Pharmaceuticals, Celestica, and Alkermes, among others. Throughout her career, Nancy has consistently demonstrated her ability to navigate complex quality and regulatory landscapes, driving strategic initiatives that have enhanced product quality, improved operational efficiency, and fostered a culture of continuous improvement.
Academic Background
Nancy holds a Bachelor of Science degree in Chemistry from the University of Massachusetts Lowell, where she graduated with distinction. Her academic achievements and strong technical foundation have been key assets in her career, enabling her to tackle complex quality and regulatory challenges with a deep understanding of the science and regulations governing the pharmaceutical and medical device industries.
Areas of Expertise
- Quality management systems design and implementation
- Regulatory compliance and inspections (GxP, FDA, EMA, etc.)
- Quality assurance and control processes
- Risk management and mitigation strategies
- Lean Six Sigma methodologies and continuous improvement
- Cross-functional collaboration and team leadership
Professional Impact
Throughout her career, Nancy has made significant contributions to the companies she has served, ensuring the delivery of high-quality products and driving operational excellence. Her expertise in quality systems and regulatory affairs has been instrumental in supporting the successful development and commercialization of numerous pharmaceutical and medical device products. Additionally, Nancy has been an active contributor to industry associations, sharing her knowledge and best practices with peers and contributing to the advancement of quality and regulatory practices in the life sciences sector.
Conclusion
With her extensive experience, deep technical expertise, and proven track record of success, Nancy Duarte-Lonnroth is a highly respected quality assurance and regulatory affairs leader in the pharmaceutical and medical device industries. In her current role as the Vice President of Quality at Praxis Precision Medicines, Inc., she continues to drive innovation, enhance product quality, and ensure regulatory compliance, making a lasting impact on the organization and the broader life sciences community.
