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Start for FreeMike Denton
SAP Project Manager, Cutover Manager, Validation Manager @United Therapeutics Corporation
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WORK HISTORY
SAP Project Manager, Cutover Manager, Validation Manager @United Therapeutics Corporation
US
Serving as the IT CSV e-Compliance Manager to ensure compliance to regulations, industry best practices, corporate policies through management of GxP compliance documents for the ERP Implementation deploying to dual business entity pharma/biotech with two manufacturing sites in the US.Serving as the SAP Project Manager to develop and manage timelines/project plans and milestones, resource allocation and tracking, status and reporting, risk management, and standard PM tools: project charters, project plans, budget charting, gantt charts, contact lists, meeting planners,landscape diagrams, presentations, transparent status management with tracking tools, and key performance indicators, issue/action item management, IT contingency and fall back plans
EDUCATION
Indiana State University
Chemistry and Business, Chemistry
SKILLS
ABOUT MIKE DENTON
A motivational leader with multiple global implementations in the Life Sciences industry for over 20 years servicing many Fortune 500 companies. An experienced professional dedicated to the on-time quality delivery of complex IT initiatives, solutions and deliverables. Focused on the development, edification and implementation of GxP CSV and Quality by Design methodologies ensuring FDA-GxP/ERES/ISO/SOX conformity of Quality Systems in the Pharmaceutical, Nutraceutical, Biotechnology, Medical Device industries. Project Management experience utilizing various SDLCs implementing the following technologies: SAP (S4 HANA/Fiori/ECC/R3, MES, Identity Management, Solution Manager, CHARM, Tao, QTP), ServiceNow, Smartsheet, MasterControl, CRM (Siebel), Microfocus ALM/HP Quality Center/, ARIS, MES, Learning Management, MetricStream, TrackWise, CAPA, SharePoint, lab equipment, and many other high risk systems- 20+ years’ experience consulting over 30 Fortune 500 companies of the Global Life Sciences’ industry in the areas of Quality Systems, Regulatory Compliance, Quality Assurance, Project Management, Information Technology, Manufacturing and Six Sigma- 7 global implementations with SAP S/4 HANA - R/3, ECC-5/6,|Fiori|MM|PP|WM|SD|QM|FICO|CRM|SD|FSRI|ChaRM, MES Systems, HPALM, Sharepoint- Engaged and partnered with internal stakeholders, the PMO and cross-functional team leads throughout the life of the project- Motivated and managed over 1,600 culturally diversified resources from 17 countries in cross-functional global off shore teams/time zones- Extensively trained and practical knowledge of current regulations including: Project Mgmt/PMBOK, Validation, Training, Document Control, Change Management Complaints, CAPA, internal/external Audits, Packaging/Labeling for compliance to 21 CFR Parts 210, 211, 820, 11; ISO 13485, and ISPE guidance.
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