David Mcdonagh Email and Phone Number
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PROFILE:I am a strategic and accomplished technology business partner, program and project management professional (PMI-PMP) and system owner with a wealth of experience in global Pharma/BioPharma environments. I have a successful track record of delivering compliant digital technologies for Quality, Manufacturing, Supply Chain and Learning organisations. Leading IT application Implementations, Change, System Integration and Migration programs (Agile, Waterfall & Hybrid) to deadline and budget that add value. I am a natural leader able to mentor, develop and manage globally dispersed high performing teams. I enjoy building relationships, collaborating cross functionally and engaging with global stakeholders.My mission is to enable and support the quality, compliance, and efficiency of a companies products and processes through innovative and robust technology solutions.KEY AREAS OF EXPERTISE:• Quality, Manufacturing & Supply Chain Applications• Digital Strategy & System Selection• Business Partner• Program & Project Management• Global IT Implementation• Team Leadership• System Integration & Ownership• Data Migration & Governance• Agile, Waterfall & Hybrid Methodologies• Cross Functional Collaboration• Stakeholder Engagement• People & Vendor Management• Change Management• System, Data, Integration, Report & Dashboard Design• Business Process Modelling, Vendor selection & System ownership• Planning & Budget Management• CSV, CSA and SDLC• Direct, Contract & Matrix Personnel Management• Mentor and Trainer• Pharmaceutical IT Application Implementation and operation• Enterprise Document Management, Quality Management, Learning Management & Laboratory Information Management Systems Implementation/Migration and Operations support expertise.• MES / QMS / EDMS / LMS / LIMS and business application evaluation & selection experience.• International success in the USA, Europe, Asia and Latin America.ADDITIONAL EXPERIENCE:Business Case Development, Business Process Mapping, Budget and Financial Management, Communication, Data Integrity, Executive Presentation, Global Application Support and Management, Infrastructure Deployment, Leader of multi-functional Business and IS/IT teams, Mentor, People Management, Priority Setting, Problem Solving, Product Serialization, Project Delivery Frameworks, Project Planning, Project Portfolio Management, Resource Allocation, Risk Management, SaaS, SDLC, Strategic Planning, System Architecture, System Integration, System Selection, Trainer, Vendor Selection, Work and Cost Estimating.
Organon
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Associate Director, Eqms Platform Business OwnerOrganon 2024 - PresentJersey City, Nj, UsBusiness Owner responsible for the Organon Global eQMS Platform and all Day-to-Day operations, support, migrations, patches and enhancements. Responsible for ensuring that the global eQMS platform and its operation are in compliance and fit for intended use as new modules are added and data migrations completed.• Responsible for representing the needs of Global Process Owners, Process Subject Matter Experts and End Users.• Business Owner for the eQMS Platform Value Stream, Oversight of PI Planning and Sprint deliverables and responsible for business outcomes.• Ensure platform compliance, data security and fit for intended use for new modules/data migrations.• Owner of the eQMS platform roadmap and internal platform enhancement backlog.
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Director, Quality System ApplicationsJazz Pharmaceuticals 2019 - 2023Dublin, IeA Director-Level Department Head, Global Program Manager and System Owner responsible for the Program Management, Implementation/Migration, Operational & Ongoing enhancements of multiple Quality, Learning & Manufacturing Enterprise IT applications. Led a team of 2 direct reports with up to 20 indirect, contract and matrix team personnel.• Quality System Applications Department Director. System owner responsible for the operational management, application / configuration management, data & dashboard management, interface monitoring and user support for all Global Quality owned Enterprise applications (eQMS [EtQ Reliance], Document Management [EtQ Reliance] and Learning Management Systems [Saba / Cornerstone SBX]).• Global Director responsible for the system ownership and delivery of multiple technology programs (Global eQMS [EtQ Reliance], Global Document Management System [EtQ Reliance], Global Learning Management System [Saba / Cornerstone SBX] and Site Laboratory Information Management System [LabWare]) using Waterfall, Agile and Hybrid methodologies.• Led multiple teams to migrate legacy GW Pharmaceuticals EDMS, eQMS and LMS data to Jazz Global platforms based on Veeva (EDMS/eQMS) or Saba (LMS).• Responsible for Program Management, Implementation, Operational & Ongoing enhancements for Quality, Learning & Manufacturing Enterprise IT applications.• Led a team to implement LabWare Laboratory Information Management System (LIMS).• Led a Global team undertaking a Business Case development and an RfI / RfP selection process for a Global MES (Manufacturing Execution System) to be implemented at 3 Manufacturing sites.• Program & Portfolio Management Lead responsible for RfI / RfP, Process Mapping, User Requirement gathering, Resource Planning, Budget & Project Planning, Risk Assessment, Change Management, Communication, IT Leadership and Implementation activities for the multiple validated applications. -
Program & Project Manager, Global Quality Systems It Application ImplementationsJazz Pharmaceuticals 2016 - 2019Dublin, IeDirector-Level Global Program / Project Manager responsible for Program Management & Implementation for multiple Quality and Learning Enterprise IT applications. Reporting to the Executive Director Quality Systems & Head of Quality. Led global teams with up to 25 matrix reports. Individual project budgetary responsibility up to €2M.• Led multiple teams of Jazz, External Contract & Vendor resources that included personnel from multiple business areas (IT, Quality, CSV, Manufacturing, Supply Chain, R&D, Compliance, L&D, etc).
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Manufacturing Systems ConsultantEnterprise System Partners Limited 2015 - 2015Manufacturing Systems Consultant that led a Front End Study to determine the value of a Manufacturing Execution System (MES) at an Oral Dose Manufacturing Facility.
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Global It Project Manager/It Lead Serialization And Product Tracking (Spt) ProjectSandoz 2015 - 2015Basel, Basel-Stadt, ChIT Lead / Global IT Project Manager responsible for the delivery of the Core Global Serialization Solution.• Responsible for the design and implementation of all global core IT and automation serialization solutions for 21 packaging sites (>140 packaging lines) in the Sandoz global packaging network.• Led a team to implement the Level 3 serialization site server solutions from 3 vendors.• Led a team to complete the design of all integrations with the Packaging Lines, SAP ERP & Werum MES. -
Global I.S. Project & Program Manager - I.S. PmoAllergan 2013 - 2014Dublin, Coolock, IeI.S. Project & Portfolio Manager that led the delivery of multiple technology projects ($5K - $2+M) supporting Allergan's business and I.S. initiatives. -
Global Project Manager (Edms - Enterprise Document Management Systems)Allergan 2001 - 2013Dublin, Coolock, IeProject Manager that led the delivery of Enterprise Document Management Solutions (EDMS) that supported Allergan's business. Provided project management services for Allergan's Global EDMS Projects.
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Supervisor, Qa Computer Systems & DocumentationAllergan 1999 - 2001Dublin, Coolock, IeDepartment Supervisor responsible for the Allergan Westport QA Document Management Department. This department was responsible for all GxP related documentation, including all manufacturing, validation, training and submission related documents.Subject Matter Expert and QA oversight for all manufacturing site computer systems.
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Electronic Signature Project Leader & Global Sap R/3 Implementation Validation SmeAllergan Feb 1999 - Sep 1999Dublin, Coolock, IeProject Leader that led the Development and Implementation of a Global Electronic Signature program for Allergan Inc. This was the first Electronic Signature application certified with the US FDA as required in 21CFR Part 11.Global SAP R/3 Implementation Validation SME.This was an 8 month assignment at Allergan Corporate Headquarters.
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Sap R/3 Implementation Testing & Validation/Documentum Integration Team LeaderAllergan Sep 1998 - Feb 1999Dublin, Coolock, IeTeam Lead that led the development and execution of the validation master plan for the Allergan Westport SAP R/3 Implementation.
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Enterprise Document Management System/Electronic Signatures Project LeaderAllergan Mar 1997 - Sep 1998Dublin, Coolock, IeProject Lead that led the Enterprise Document Management System (EDMS) & Electronic signatures project for Allergan Pharmaceuticals (Ireland) and Allergan Botox (Ireland) Limited.
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Validation EngineerAllergan Sep 1995 - Mar 1997Dublin, Coolock, IeResponsible for the validation of equipment, facilities and processes used by various production departments within Allergan Pharmaceuticals (Irl.) Ltd., Westport. Definition and development of Allergan Ireland’s policy on software validation requirements.
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Microbiology TechnicianAllergan Jun 1995 - Sep 1995Dublin, Coolock, IeSummer Job employed as a Microbiology Technician to perform Environmental, In-Process Product Testing and Validation activities.
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Microbiology TechnicianAllergan Pharmaceuticals Jun 1994 - Oct 1994Dublin, Coolock, IeSummer Job employed as a Microbiology Technician to perform Environmental, In-Process Product Testing and Validation activities.
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Microbiology TechnicianAllergan Pharmaceuticals Jun 1993 - Oct 1993Dublin, Coolock, IeSummer Job employed as a Microbiology Technician to perform Environmental, In-Process Product Testing and Validation activities.
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Microbiology TechnicianAllergan Pharmaceuticals Jun 1992 - Oct 1992Dublin, Coolock, IeSummer Job employed as a Microbiology Technician to perform Environmental, In-Process Product Testing and Validation activities.
David Mcdonagh Skills
David Mcdonagh Education Details
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Maynooth UniversityChemistry -
St. Gerald'S College
Frequently Asked Questions about David Mcdonagh
What company does David Mcdonagh work for?
David Mcdonagh works for Organon
What is David Mcdonagh's role at the current company?
David Mcdonagh's current role is Digital Program & Project Management Leader in Pharma & Biotech | IT Business Partner | IT Project Manager leading Teams | Manufacturing & Quality Applications | IT Program / Project Manager | PMO | Business Owner.
What is David Mcdonagh's email address?
David Mcdonagh's email address is mc****@****gan.com
What is David Mcdonagh's direct phone number?
David Mcdonagh's direct phone number is +353163*****
What schools did David Mcdonagh attend?
David Mcdonagh attended Maynooth University, St. Gerald's College.
What skills is David Mcdonagh known for?
David Mcdonagh has skills like Pharmaceutical Industry, Project Management, Quality Assurance, Document Management, Sop, Computer System Validation, Gxp, Integration, Edms, Pmp, Process Improvement, Change Management.
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