Laura Leal
About Laura Leal
Laura Leal serves as the Senior Director of QA & RA at Singular Genomics, where she has worked since 2023. With extensive experience in quality assurance and regulatory compliance across various companies, she has developed strong leadership skills and expertise in implementing Quality Management Systems.
Work at Singular Genomics
Laura Leal has been serving as the Senior Director of Quality Assurance and Regulatory Affairs at Singular Genomics since 2023. In this role, she is responsible for overseeing the development and implementation of quality and regulatory strategies that ensure product approval and certification maintenance. Her leadership in this position reflects her extensive experience in the field.
Previous Experience in Quality Assurance and Regulatory Affairs
Prior to her current role, Laura Leal held several significant positions in the quality assurance and regulatory affairs sectors. She worked at CR Bard as a Senior Compliance Specialist from 2007 to 2013. She also served as the Director of Global Corporate Compliance Quality Assurance at Luminex Corporation for one year in 2020-2021, and as a Q.A./R.A. Manager at Hill-Rom from 2013 to 2016. Additionally, she was a Senior Quality Assurance Manager at REVA Medical, LLC for six months in 2023.
Education and Expertise
Laura Leal earned her Bachelor of Science degree in Organizational Behavior Studies from the University of San Francisco. She also studied at Southern Polytechnic State University, where she was a candidate for a Master of Science in Quality Assurance. Her educational background supports her expertise in implementing Quality Management Systems (QMS) and compliance with various international standards.
Career Development at Medtronic Vascular
Laura Leal's career includes extensive experience at Medtronic Vascular, where she held multiple roles over several years. She worked as a Quality Assurance Auditor from 2001 to 2003, then as a Q.A., R.A., and Clinical Compliance Auditor from 2003 to 2006. She continued her career there as a Manufacturing Supervisor from 2000 to 2001, and later as a Senior Q.A. R.A. and Clinical Compliance Auditor from 2006 to 2007.
Skills and Specializations
Laura Leal possesses strong leadership and strategic analysis skills, particularly in the development and implementation of quality and regulatory strategies. She has expertise in site inspection preparation and remediation processes. Her ability to interface and collaborate effectively has enabled her to lead and train teams successfully. She is knowledgeable in various international quality standards, including 21 CFR 820 and ISO 210.