30 years quality and regulatory professional with experience managing systems and programs with a common sensed approach. Set up multi-site company’s quality organization infrastructure with Quality Management Systems to set the overall intention and direction of the organizations with respect to quality and regulatory compliance. Initiating and delivering sustained change results and effective change across a wide range of industries including food, dietary supplements, pharmaceuticals and… Show more 30 years quality and regulatory professional with experience managing systems and programs with a common sensed approach. Set up multi-site company’s quality organization infrastructure with Quality Management Systems to set the overall intention and direction of the organizations with respect to quality and regulatory compliance. Initiating and delivering sustained change results and effective change across a wide range of industries including food, dietary supplements, pharmaceuticals and hazardous waste. Major experience lies in strategizing and leading cross-functional Teams to bring about fundamental change and improvement in strategy, process, external customer service and profitability. • Ensure compliance with governing bodies, including the FDA, USDA, DOT, EPA, Health Canada, EU, FSANZ and multiple states agencies.• Trained and Lead Teams that upgraded/re-wrote the Supplier Control Program and HACCP Plan to meet FSMA requirements of HARPC. • Responsible for managing company's Adverse Event reporting and Complaint by CAPA processes, including failure investigation tracking and trending activities, reporting, and CAPA implementation effectiveness.• Developed and implemented multiple quality management systems to secure compliance with the needed standard at the organization, ISO, BRC, SQF, ICH Q10.• Create and ensure quality standards in compliance with relevant regulatory guidelines such as 21CFR Part 110/117, 111 and 210/211 requirements.• Led cross functional teams that monitored, analyzed, and redesigned processes and procedures in simplification of SSOP’s, SOP’s and forms. • Mentored staff at various facilities through multiple standards and regulatory changes that resulted in 100% compliance with regulatory, 3rd party and customer audits.• Introduced continuous improvement concepts such as Lean and the use of VSM, 5S, statistical methods, root cause analysis and standard work. Show less

In charge of inventory and scheduling.