Mark Weber Email & Phone Number

Allentown, Pennsylvania Area

Provide configuration, validation and data migration services expertise, and project and technical support for Quality Systems' implementations and upgrades within the Life Sciences Practice. Engagements have included: Regeneron Pharmaceuticals - QMS Upgrade (QUMAS/BIOVIA ProcessCompliance) (Aug 2023 - Oct 2023)- Validation SMETakeda Pharmaceuticals - DMS-LMS Global Platform Consolidation (2021-2023)- LMS Migration Lead - Migration of all corporate TalentSuite & Saba GxP and non-GxP training data into target SAP SuccessFactors environmentsTakeda Pharmaceuticals - LMS Deployment (PeopleFluent TalentSuite) (2016-2019)- Phase 1 (US/Japan) LMS configuration/testing SME & Data Migration lead (ETL)- Phase 2 LMS Migration Lead for 80+ site global rolloutAssociates of Cape Cod (ACC) - LMS Deployment (PeopleFluent TalentSuite) (2015-2021)- Configuration/testing/report SME- Data migration lead (ETL)- Validation lead- Subsequent platform upgrade planning/support/validation project memberACC - LIMS Vendor Selection, Implementation (LabVantage) (2018-2022)- Facilitate, author RFP collateral; lead vendor selection process- Validation lead for Phase 1 implementationPolyPeptide Laboratories - LMS Deployment (PeopleFluent TalentSuite) (2016-2018)- Configuration/testing/report SME- Data migration lead (ETL)- Multi-phased global implementation (US/EU/India)Novavax - QMS Upgrade - LMS Deployment (PeopleFluent TalentSuite) (2021-2022)- Configuration/testing/report SME- Data migration lead (ETL)- Validation lead- Post go-live supportNovavax - LIMS Vendor Selection Processes (LabVantage) (2017-2018)- Facilitate, author RFP collateral; lead vendor selection process

Dracut, Massachusetts, United States

Sunovion Pharmaceuticals - Global LMS Platform Consolidation Project (SumTotal Learn) (2018-2022)- Project Manager for RFI/RFP, vendor selection of Enterprise LMS solution- Configuration SME- Validation lead- Data migration lead (ETL)- Post Go-Live supportSunovion Pharmaceuticals - BIOVIA EDMS/LMS Global Implementation (2014-2015)- Project Manager- Implementation/deployment lead- Configuration SMELantheus Medical Imaging - IT Senior Technical Advisor, Project Manager (2012-2017)Provided technical & business process knowledge, validation services, issue resolution and project management services for numerous IT systems and/or enhancement/upgrade projects, such as:- TechneLite® Generator SCADA system- Online/offline label systems- Enterprise BIOVIA EDMS, ISOtrain LMS systems- BIOVIA & AssurX Process Management systemsShire HGT - R&D BIOVIA EDMS (2012-2014)- Project Manager- Implementation/deployment lead- Configuration SME- Post go-live System Administrator (including Tier1/2 support, validation maintenance)Shire HGT - LabWare LIMS performance assessment (2014-2015), responsibilities including:- Evaluating and documenting the LIMS architecture- Developing detailed application-centric process flow narrative- Identifying opportunities and developing plan for improved system performance

Associate Director, Operations, Quality and R&D Business Systems (2011-2012)Member of the IT and Lantheus Senior Leadership Teams (SLTs), responsible for IT strategic development, operational continuity planning and execution and continuous improvement activities, and client relationship management of the Technical Operations, Quality, R&D and eDMS user communities.Manager, Manufacturing and Document Management IT Systems (2008-2011)Member of the IT leadership team, responsible for client relationship management of the Technical Operations, Quality, R&D and eDMS user communities, as well as validation maintenance and lifecycle management of their IT systems.Systems Analyst, Bristol-Myers Squibb (2002-2008)IT focal for >20 regulated (cGMP) and/or non-regulated applications/systems used in Technical Operations; systems included SCADA, labeling, environmental monitoring/analysis and palletizer systems.