Andrew Stasiak

Andrew Stasiak has a diverse work experience in the field of quality assurance and regulatory compliance. Andrew started their career in 2005 as a Research Associate at Ventana Medical Systems, where they were involved in manufacturing, packaging, and quality assurance of research products. In 2007, Andrew worked as a Bioscience Product Specialist at Molex, managing key accounts and developing new technologies in genomics and proteomics. Andrew then joined Jubilant HollisterStier Contract Manufacturing & Services as a Supervisor of Analytical Quality Control, implementing quality management systems and performing HPLC method development. In 2011, Andrew became the Director of Quality Assurance at Insys Therapeutics, where they built the company's quality system and ensured compliance with regulatory requirements. From 2016 to 2019, they were the Global Clinical Quality Assurance Leader at W. L. Gore & Associates, overseeing quality assurance functions and leading clinical trials in the Asia Pacific region. Andrew Stasiak then joined Medivant Healthcare in 2019 as the Vice President of Quality, where they played a crucial role in bringing the company from initial development to FDA compliance. Currently, they are serving as the Senior Director of GxP Quality Assurance at Marinus Pharma, where they manage quality assurance activities.

Andrew Stasiak completed their education with a Master's of Science degree in Regulatory Affairs from San Diego State University in the years 2013-2015. Prior to that, they obtained a Bachelor of Science degree in Molecular and Cellular Biology from the University of Arizona from 2000-2005. In addition to their degrees, they also hold certifications such as Certified Quality Auditor (CQA) from ASQ - World Headquarters, and Registered Quality Assurance Professional - Good Clinical Practices (RQAP - GCP) from the Society of Quality Assurance.