Tita Simmons

Tita Simmons, MS, RAC, CQA, CQM, CSSBB, RQAP-GCP has an extensive work experience in quality assurance and regulatory compliance. Tita has held various leadership roles in reputable companies such as Merz Aesthetics, PRA Health Sciences, Health Decisions, Copernicus Group IRB, Duke Clinical Research Institute, PPD, Encysive Pharmaceuticals, i3 Research, Eisai Medical Research, and Baxter Healthcare.

Tita'sresponsibilities have included overseeing global GxP quality in biologic, drug, and medical device product development, managing quality systems, conducting audits, implementing process improvements, ensuring regulatory compliance, and providing strategic guidance to internal and external stakeholders. Tita has demonstrated expertise in GCP, GLP, GMP, GDP, ISO 9001, ISO 13485, and Lean Six Sigma methodologies. Tita has also managed budgets, mentored teams, and contributed to revenue generation.

Tita Simmons, MS, RAC, CQA, CQM, CSSBB, RQAP-GCP, obtained a Bachelor of Science Degree in Chemistry from Kean University in 2002. Tita then completed their Master of Science Degree in Quality Assurance & Regulatory Affairs from Temple Graduate School of Pharmacy from 2003 to 2006. Tita Simmons also holds several additional certifications, including ISO 13485:2016 Lead Auditor, ISO 9001:2015 QMS Lead Auditor, ISO Internal Auditor, Certified Quality Auditor (CQA), Certified Quality Manager (CQM), Certified Six Sigma Black Belt (CSSBB), Executive Leadership Certificate Program, Registered Quality Assurance Professional-GCP (RQAP-GCP), and Regulatory Affairs Certification (RAC). The institutions from which they obtained these certifications include BSI, Bureau Veritas, North Carolina State University, ASQ - World Headquarters, Duke University, and the Regulatory Affairs Professionals Society (RAPS). The specific years of obtaining these certifications are not provided.