Dennis Laporte Email & Phone Number

I have approximately 25 years of experience in the GxP Biotechnology, Pharmaceutical, and Medical Device industries. My expertise lies in Quality Assurance, focusing on compliance, Quality Management systems, eQMS deployment (Veeva, MasterControl, etc.), Vendor and Audit Management. As a Quality Assurance leader and consultant, I help biotech and pharmaceutical companies develop, implement, and manage QA strategy, QA management systems, training, and procedures based on successful results in GxP-regulated environments. I have led the transformation of multiple companies from paper-based systems to electronic Quality Management Systems (eQMS), such as Veeva and MasterControl. My knowledge also extends to drug/device development and associated regulatory requirements. I am a self-starter and collaborative relationship builder, accustomed to working in a demanding, fast-paced environment with continuous change and ambiguity. I am effective at working independently or as part of a team. I have experience working across all levels of the Quality organization, building a QA culture, managing external partners, and engaging with senior leadership to achieve continuous quality improvements.Competency in: eQMS creation and deployment, Gap assessment projects, Cell therapy, and Cell culture operations, Batch record creation and review, Supplier/Vendor Quality Management, Internal/External auditing, Deviation, CAPA and Change control management, Risk Assessment, Regulatory remediation (warning letter and consent decree), Technical document writing, Managing CMO's, Specification development and review, Annual product review, Method transfer, analytical instrument qualification, and validationSystems experience:LMS systems, TrackWise, LIMS/StarLIMS, LiveLink, Microsoft platforms, SharePoint, ERP Systems (Oracle and SAP), MasterControl, Veeva

Listed skills include Laboratory, Elisa, Root Cause Analysis, Gmp, and 27 others.