Veeva Implementation Leader
Princeton,NJ
Summary
- Experienced Leader delivering strategic IT solutions and system development along with Laboratory Operations Management in support of Pharmaceutical Quality and Laboratory Operations. Proven track record in delivering key Laboratory & Quality Management System information technology projects on time and on budget to provide a competitive advantage in a global and highly regulated CGMP environment. Adept relationship builder with a proven track record of successful facilitation of strong partnerships at all levels of IT and Quality and R&D along with Business Senior Management Teams.
- Implemented and delivered enterprise initiatives to consolidate and harmonize Lab Data acquisition, SDMS, LIMS and QMS applications including Trackwise, Veeva Vault Platform (various applications) and MasterControl in a centralized and cost effective model.
- Implemented Global Laboratory Information Management System (GLIMS) to support global Analytical, Microbiological and Environmental Monitoring Testing at 27 sites globally which included integration to lab data systems, MES and ERP system.
- Developed and implemented Global TrackWise Quality Management System (QMS) that supported 34 sites supporting, CAPA, Deviations, Change Management, Quality & 3rd Party Audit Tracking, Compliance Metrics, Customer Complaints and Supplier Quality Mgmt providing end to end visibility. Recently implemented Veeva’s full Quality Vault environment to provide a strategic advantage for a major Generic Pharma company.
Overview
44
44
years of professional experience
Work History
IT Veeva COE Leader
Client
09.2020 - Current
- Responsible for working and collaborating closely with business leaders to understand business strategy, demand, and priorities and help the business propose and then lead projects that leverage the Veeva Platform
- Responsible for leading, developing and executing a plan to build a Veeva COE Team which will be a high performance, efficient and effective team providing value across the business areas that use Veeva products
- Lead/manage the support of the Veeva applications through managed support and stakeholder relationships, as well as participate in road-mapping for future Veeva upgrades and implementations
- Key areas of responsibilities include:
- Strategy and Planning
- Acquisition and Deployment
- Operational Management
- COE Team Development & Leadership
IT Business Partner
Client
11.2019 - 08.2020
- Consulting Support to QMS Implementations – ComplianceWire LMS, ETQ QMS
- Veeva DMS and to work to move all to the Veeva Platform in the not so distant future
- Consulting Support to R&D applications Roadmap leveraging Veeva
- Consulting Support to Quality Control and Analytical Sciences application Roadmaps
Senior Manager - Commercial IT
Client
01.2014 - 10.2019
- Leading implementations, administer methods and procedures to enhance operations based on industry best practices leveraging cloud technology focusing on Veeva’s entire Vault Platform
- GAMP5 guidelines along with Veeva Commercial systems Veeva CRM and Promomats not to mention Veeva Systems in the R&D/Clinical space like eTMF, CTMS & Submissions in the
- Responsible for leading implementation and supporting Laboratory, Quality and R&D systems required for Quality Management & drug development in the cGMP environment
- Working with business users to improve existing processes to allow them to be automated and recommends, implements business / technology solutions to various functional areas
- Managed the application implementation & support of Quality and R&D systems to ensure they met business needs and user requirements, to remain in compliance per cGMP requirements and
- Regulatory space.
Associate Director IT
Global Pharma Client
01.2009 - 01.2014
- Implemented Global cloud-based Artwork Management system to consolidate Manufacturing packaging artwork capabilities in support of a global initiative to outsource and eliminate in-house artwork centers around the globe. This effort was a key contributor in an overall initiative with cost savings of $48M annually and IT support cost for the legacy systems of more than $8M annually.
- Lead Business, information, solution architecture and project team for consolidation of multiple site LIMS, CDS, SDMS & TrackWise systems across Manufacturing into global systems. These efforts reduced risk, increased compliance across 34 sites and provided benefits of $28M in annual savings along with more than 50% reduction in support/operational costs.
- Laboratory Systems i.e. Chromatography Data Acquisition, LIMS, and SDMS
- Quality Management System (QMS) i.e. TrackWise Global Artwork Management
Senior Manager
Client
01.2005 - 01.2009
- Global Laboratory and Quality IT Systems
- Global LIMS, Empower and Nugenesis
- Provided managerial and technical direction for $15M Global LIMS project
- Responsible for project oversight and direction in conjunction with Global Quality Business Owner and Business Director
- Project Team Leader tasked with developing strategy for an overall near-paperless lab for Global
- Quality Lab Operations
- Leadership and management of Global LIMS selection process
- Global deployment planning and infrastructure strategy
- SDLC strategy development
- Provided oversight of design, development, testing, validation, implementation and support
- Managed $33M Global Laboratory systems capital budget
- Parallel projects included interfacing various business systems including Labware LIMS
- Empower, Nugenesis, ERP and MES
Manager
01.2002 - 01.2005
- In the Technical Operations Information Technology department responsible for the management, implementation and oversight of regulated system projects in Schering Labs Global
- Quality Operations
- Developed standards, protocols and procedures to insure compliance and direct oversight of regulated systems projects worldwide for adherence to GXP’s and heightened 21CFR Part11 scrutiny by regulatory agencies
- Provided auditing/validation support/project management support
- User requirements gathering, AR preparation, program planning and implementation
- Liaison between Quality Operations, Technical Operations IT and Corporate IT groups
Manager Information Technology
Client
01.1997 - 01.2002
Supervisor, Operational Support
Client
01.1984 - 01.1997
- Acting as a liaison between the Q.C
- And Information Systems departments provided technical and computer validation support to US QC and international QC sites in Puerto Rico, Ireland, Miami and
- Singapore
- Provided building management, technical and operational support for QC testing laboratories atNJ sites supporting both Analytical and Microbiological testing
- Administered calibration program for Analytical and Biological instrumentation including all building system
- Provided instrument repair and trouble-shooting services for all Laboratory instrumentation including administration of instrument service vendors, service contracts, and Sub Contract
- Services
- Negotiated instrument purchases, service contracts, investigated and developed measures to reduce operating expenditures
- Implemented first Chromatography Data Management System in Global Quality
- Operations and subsequently deployed globally at 14 sites around the world.
Field Sales & Service Engineer
Client
01.1981 - 01.1984
- Responsible for the Sales, installation, validation, calibration and maintenance of HPLC and microcomputer based data acquisition systems in a northern NJ territory, which included numerous major pharmaceutical companies and universities.
QC Methods Development Chemist
Client
01.1980 - 01.1981
- Responsible for development, validation and roll out new analytical methods ensuring a high level of analytical rigor is applied to method development projects
- Support development and training of laboratory personnel and ensuring maintenance and calibration of specified analytical instrumentation appropriate standards and other work in support of future projects or lab developments.
Education
BS - Chemistry
Stevens Institute of Technology
Hoboken, NJ1980
Skills
- Large Scale Veeva Implementation
- Strategy and Planning
- Acquisition and Deployment
- Operational Management
- COE Team Development & Leadership
Affiliations
PhRMA, PDA, ACS, ASQ, ISPE, ASTM, SmartLab Exchange (Chairman 2009 IQPC SmartLab
Exchange Symposium, UK), GuidePoint
Timeline
IT Veeva COE Leader
Client
09.2020 - Current
IT Business Partner
Client
11.2019 - 08.2020
Senior Manager - Commercial IT
Client
01.2014 - 10.2019
Associate Director IT
Global Pharma Client
01.2009 - 01.2014
Senior Manager
Client
01.2005 - 01.2009
Manager
01.2002 - 01.2005
Manager Information Technology
Client
01.1997 - 01.2002
Supervisor, Operational Support
Client
01.1984 - 01.1997
Field Sales & Service Engineer
Client
01.1981 - 01.1984
QC Methods Development Chemist
Client
01.1980 - 01.1981
BS - Chemistry
Stevens Institute of Technology
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