Ms. Simkins Will Be Responsible for Overseeing Global Quality Assurance (QA) Operations, Continuing to Uphold BioAgilytix’s Efficient and Effective Compliance Program
AUGUST 16, 2016—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the promotion of Anita Simkins to Vice President of Global Quality Assurance. In this new role, Ms. Simkins will be responsible for overseeing global QA operations, both in BioAgilytix’s North Carolina-based U.S. headquarters and at its new European laboratory located in Hamburg, Germany.
Collectively Ms. Simkins brings more than 23 years of experience working in CLIA, ISO, GMP, GLP and GCP environments within pharmaceutical, diagnostic, biotechnology and clinical research organizations. Her previous experience includes tenures as a QA Manager at BioCryst, AlphaVax, and Trimeris, as well as roles as a clinical auditor at Kendle and Quintiles. She has developed and implemented Quality Management Systems in compliance with US/EU regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and bioanalytical analysis for small and large molecules.
At BioAgilytix, Ms. Simkins provides strategic and managerial oversight of QA operations including developing, communicating, and implementing standards that assure BioAgilytix GxP operations present minimum risk to the company. In her time with the company, she has led the development and implementation of efficient and effective compliance programs to satisfy Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulatory requirements. “Anita has done a tremendous job of fostering a high-performance QA team for BioAgilytix, and supporting our strong regulatory track record,” said Jim Datin, Chief Executive Officer of BioAgilytix. “We’re thrilled to be able to further evolve her role as an integral part of our leadership team, as she helps us extend our robust QA operations on a global scale, and uphold our industry-leading quality.”
“It has been very rewarding to grow with BioAgilytix over the years, and to help them fortify a QA group that I consider to be among the best in the industry,” said Ms. Simkins. “I look forward to continuing my work to provide our customers – globally – with the highest levels of quality that they can confidently depend on.” Ms. Simkins has a BS in Clinical Laboratory Science from East Carolina University and maintains two certifications: American Society of Clinical Pathology and Register Quality Assurance Professional–GLP. She is also a member of the Society of Quality Assurance and currently a Director of Issues and Methods on the North Carolina Chapter of the Society of Quality Assurance.
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, GCP, and GCLP, as well as product release testing under GMP.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.