Maria N.
About Maria N.
Maria N. is the Manager of Global GCP Inspection Excellence at BeiGene, with over 15 years of experience in quality assurance and regulatory compliance in the pharmaceutical industry.
Current Position at BeiGene
Maria N. is currently serving as the Manager of Global GCP Inspection Excellence at BeiGene. In this role, she oversees the adherence to Good Clinical Practice (GCP) standards across a variety of clinical trials and projects. Her responsibilities include managing inspection readiness, conducting internal and external GCP inspections, and collaborating with international teams to ensure global compliance with regulatory standards.
Previous Experience at Technical Resources International, Inc.
Maria N. worked as an RSC QA Manager at Technical Resources International, Inc. from 2020 to 2021. During her tenure, she was responsible for overseeing quality assurance activities and ensuring that the company adhered strictly to regulatory compliance standards. Her role included managing quality audits and inspections and collaborating with different departments to uphold the standards set forth by various regulatory bodies.
Quality Assurance Roles at Lexicon Pharmaceuticals, Inc.
From 2015 to 2020, Maria N. worked at Lexicon Pharmaceuticals, Inc. in The Woodlands, TX. She held roles as Quality Associate II in GCP QA and Quality Assurance Specialist II in GMP. In these positions, she ensured compliance with both Good Clinical Practice and Good Manufacturing Practice regulations. Her duties encompassed conducting quality audits, managing documentation, and working on quality assurance initiatives to support clinical trials and pharmaceutical manufacturing.
Educational Background and Early Career
Maria N. studied at Ramapo College of New Jersey, where she earned a BS in Biology and Chemistry from 2002 to 2007. Prior to that, she attended Dr. Charles E. Brimm Medical Arts High School from 1998 to 2002 and also studied at St. Joseph Pro Cathedral. With a strong foundation in the sciences, Maria began her career in quality assurance, rapidly gaining expertise in regulatory compliance and technical writing.
Quality Assurance Specialist at Fisher Clinical Services
Maria N. worked at Fisher Clinical Services as a Quality Assurance Specialist from 2007 to 2013 in Bristol, PA. She was involved in various quality assurance activities, including conducting audits, managing documentation, and ensuring compliance with Good Manufacturing Practice (GMP) standards. During her six-year tenure, she built extensive experience in quality assurance within the pharmaceutical industry.