Over 25 years of experienc as project director/senior program and project manager of quality and senior capital project manager. Experienced with successfully delivering of high risk, mission-critical projects in highly regulated environments. Directed multi-million dollar capital projects providing senior management oversight and engineering for greenfield or brownfield projects. Projects included manufacturing processes (sterile injectables, oral liquid/tablet/capsule and topicals) for biotech, pharmaceutical, medical devices and QC Testing Laboratories. As program manager performed assessment and provied management direction for restucturing of operatonal and production and quality systems for regulated GMP industries. Systems including but not limited too, BOM, Batch Records, MRP, ERP (SAP system upgrades), Change Control, LIMS and oversight for Data integerate and Cyper Security for Automated Production Process and Computerized date collection and historian systems. Experienced in on-site and remote management of multiple projects simultaneously while managing client staff, contract personnel, third party partners and vendors. Engineering disciplines including electrical, mechanical, process (biological, pharmaceutical and medical devices), automation processes, SCADA, building automation, physical and logical cyber security, validation and regulatory compliance groups. Successfully directed department restructuring and mergers. Provided direct management and oversight for production (biological, pharmaceutical and medical devices), quality assurance/control, IT departments and laboratories.Successfully directed several clients through FDA levied Warning Letters and Consent Decree re-starts. All projects completed on-time or ahead of schedule, on or under budget.