Dedicated Quality Assurance and Regulatory Operations professional with a proven track record in optimizing business performance within the pharmaceutical industry. Demonstrated expertise in effectively managing controlled documentation for leading pharmaceutical companies, ensuring compliance with rigorous regulatory standards. Renowned for making a significant impact on quality in highly regulated and dynamic environments supporting Research & Development (R&D) and manufacturing operations. Key contributor to the maintenance and enhancement of a robust Quality Management System, adept in crafting standard operating procedures, work instructions, and forms using meticulous documentation processes in GxP, GMP, and GCP environments. Core competencies include:Vault Quality| SOP Manager, ESOPS | Document Management | Quality Systems Management | Audit Interface| Advanced Word Processing | Instructor-Led Training | Staff Development | Problem Identification| Tracking and Trending Analysis | ISO/FDA Regulation | Archiving Specialist | TMF | Technical EditorTECHNICAL COMPETENCIESVault Quality Documents | ESOPS D2, EDMS - Documentum | Webconsumer | ACE | SharePoint | eDocs | Pilgrim SmartSolve | ISIWriter DocuSign | PKI | Global Document Management System| Product Event | Registration Licenses| TRACTsAdobe Acrobat | Vault RIM | AbbVie Connect | MS Office | Visio | ComplianceWire | Up4Growth | ISOTrain