Orinthal Mcintyre, Ms, Mba Email and Phone Number

Highly talented and experienced Quality Assurance professional with a strong background in current Good Manufacturing Practices (cGMP), U.S. Food and Drug Administration (FDA), Change Control management, and Corrective and Preventive Action (CAPA) for clinical and commercial biological products. In depth knowledge of European Union (EU) and International Conference on Harmonization (ICH) cGMP regulations and guidelines along with a demonstrated working history of superior quality leadership and outstanding performance in the bio-pharmaceutical industry.Experienced in leading departments/teams, providing excellent Quality Assurance guidance and support for all aspects of clinical and commercial manufacturing operations, including Audit/Inspection Readiness, Lot Release/Disposition of drug substance, drug product, and finished drug product. Advanced knowledge of Quality Operational Systems, excellent communication and presentation skills, with demonstrated ability to effectively communicate with and lead multi-cross functional departments and teams. Areas of expertise include the following:• Quality Assurance (QA)/Leadership• FDA/EU/ICH guidelines and regulations •cGMP• Manufacturing•CAPA/Deviations/Change Controls•Audit/Inspection Readiness