Quality Professional in the Pharmaceutical and Biotechnology industries with expertise in QA Document Control, Quality Systems and Training. Accomplished in building quality management systems and a record of driving continuous process improvement, implementing best practices, and leading and motivating teams. Knowledgeable of Good Manufacturing Practice guidelines (GMPs) and regulatory guidances.Skills:• GMP Regulations, Quality Systems• Regulatory Inspection support and interaction with Regulatory Authorities• People management• Budgeting and management of functional area resources• Expertise in configuring, implementing, and oversight of Electronic Document Management Systems (eDMS) and Learning Management Systems (LMS)• Method Validation and Transfer• Equipment Validation• Computer System Validation• Microsoft Office Programs: Word, Outlook, Excel, Access, Visio, PowerPoint• Additional Programs: MasterControl. ComplianceWire, Veeva, ensur, Trackwise, DocuSign, SharePoint, Box