Tiffany L. Galt
Reading
Summary
Experienced leader in Quality Assurance and Information Management System Projects, specializing in Quality Management Systems. Successfully delivered critical SAAS project components, including Supplier Quality, Document Management, and CAPA processes, ensuring compliance with regulatory standards. Demonstrated ability to prioritize high-impact initiatives while fostering effective team collaboration. Adaptable in dynamic environments, consistently driving growth and overcoming challenges.
Overview
28
28
years of professional experience
Work History
Group Project Manager
HCL Technologies Consulting
04.2018 - 10.2024
- Managed IT Business and Data Analysis Projects for Pharmaceutical work streams in the Merck Manufacturing and Clinical Quality Management System Projects that resulted in a 30% reduction in project delivery time.
- Lead IT Representative for Project Planning and Business Process Modeling workshops that engage with key Business Stakeholders and Customers of SAP Quality Management and Accelerate Batch Disposition projects using Waterfall and Agile Methodologies.
- Led Data Migration efforts and SDLC deliverables for the Change Management Project from Trackwise Systems to Veeva Quality Vault using 21 CFR Part 11 Regulations, GMP, ICH9, GCP, ETL, GxP, Data Integrity and Privacy Standards.
- Demonstrated IT Project Management and Scrum master techniques while acting as a liaison to Business Project leaders and ensuring that Software Development Lifecycle compliance is met during delivery of the IT Systems deliverables below using IT Change Management principles and ITIL practices in ServiceNow.
- Managed and trained offshore hosted vendor resources for Manual and Automated Software Validation and Testing resulting in a 25% increase in project efficiency; Led Business Analysts in Quality Management Systems’ (QMS) Projects.
- Collaborated and Communicated with Program Managers and Delivery Leads on Portfolio Management Statuses, Risks, and Prioritizations.
- Communicated with Team Members during Product Backlog and Daily Sprints Meetings which led to multiple IT projects being implemented each year from 2017 to 2024.
- Managed Expectations with Business Leaders and cleared roadblocks within the team ensuring projects are delivered in compliance with IT Quality standards.
- Transitioned from Lead Business Analyst to Project Manager Role for Pharmaceutical work streams in Merck Clinical Quality Projects (vaccines and clinical trial products) and Manufacturing Quality Projects.
- Supported implementation of Quality Management Metrics, Data Modeling, Predictive Analytics Projects in Tibco Spotfire/EBX, QLIK in Tableau, SAP Business Objects/Intelligence, and metadata stored in Data Lake solutions.
- Participated in Architectural design reviews to identify metadata that would be extracted/transformed/loaded from the source systems through the IPaaS middleware (Google Cloud Platform) to the Target application.
IT Business Systems Analyst – RA/QA Vertical
Teleflex Medical
01.1997 - 01.2017
- Company Overview: Formerly Arrow International Inc.
- Managed SAP QM/PM incidents and configuration/development change requests post go-live in the Regulatory, Quality Management, Complaints Management/Post-Market Surveillance, and Calibration/Plant Maintenance Business Areas globally for Critical and Cardiac Care Medical Devices.
- Member of SAP SCM Global Implementation Team for SAP QM and PM Manufacturing projects.
- Standardized the Implementation of a Global Non-Conformance Process Change in SAP affecting fields, configuration, workflows, processes, reporting, training, and screen elements in 2016.
- Transitioned after 7 years in Regulatory Quality Assurance Organization to IT Development Organization supporting Quality Management System applications and Projects.
- Directed offshore developers in the design and system development of SAP Quality Change Requests.
- Developed Functional Requirements and Functional Design Specifications, Trace Matrixes, IQ, OQ and PQ scripts for Domestic and International facility Quality Software. (Q&MIS Software and Trackwise).
- Gathered, Defined, Developed and Documented user requirements for business applications and RA/QA reporting in SAP and BW.
- Implemented Electronic Medical Device Reporting (EMDR) in SAP meet FDA regulatory compliance using HL7 ICSR xml format in 2015 for Adverse Events and Vigilance Reporting.
- Created, Designed and Developed software documentation such as IT Project Charters, User Guides, and Training Materials.
- Ensured Quality Application adherence to FDA QSR Regulation, 21 CFR 820 and ISO 13485 (2003).
Education
Business Management
Reading Area Community College
Reading, PASkills
- Project management
- Data analysis
- Quality management
- Agile methodologies
- Regulatory compliance
- Software validation
Professional Development
- PM Training PMP Exam Preparation Course - 5 Day Bootcamp, 2024
- Certified Scrum Master Certification, 2024
- Microsoft Office Suite/Teams/Visio/Excel, 1997 - 2024
- Export Compliance, Information Security, and COBEC Training, 2017 - 2024
- Regulatory, Quality, Change and Product Lifecycle Management System Process Training, 1997 - 2024
- Documentum Open Text Training, 2021
- Jira, Confluence, SharePoint, 2019
- Scrum, and Agile Training, 2019
- Service Now, 2019
- Veeva Vault Software/SmartSheet/Lucid Web/Power Business Intelligence Training, 2019
- MetricStream SAAS Risk Management System Training, 2019
- Tibco Spotfire/Tableau Training, 2017
- ALM Vera Training, 2019
- Business Analysis for the IT Professional Training, 2011
- ITIL V3 Foundation Certification, 2011
- HP Quality Center Testing, 2011
- Crystal Reports 2008 – Design 1 and 2, 2011
- Agile PLM (acquired by Oracle), 2011
- SAP PLM 415 Quality Management in Logistics Training, 2010
- SAP PLM 400 Quality Management Training, 2010
- SAP PLM 412 Quality Inspection and Planning Training, 2010
- Transact SQL Training, 2010
- Trackwise Quality Software Administrator Training, 2007
- Cadence Project Management Certification, 2006
Timeline
Group Project Manager
HCL Technologies Consulting
04.2018 - 10.2024
IT Business Systems Analyst – RA/QA Vertical
Teleflex Medical
01.1997 - 01.2017
Business Management
Reading Area Community College
Similar Profiles
Srinivasan NandagopalSrinivasan Nandagopal
ETL Lead /Onshore Technical Business Analyst at HCL Technologies India & HCL Technologies NZ LtdETL Lead /Onshore Technical Business Analyst at HCL Technologies India & HCL Technologies NZ Ltd
Dan WyszynskiDan Wyszynski
Senior Mortgage Loan Closer at HCL Technologies/HCL Lending ServicesSenior Mortgage Loan Closer at HCL Technologies/HCL Lending Services
Sudhanshu ShekharSudhanshu Shekhar
Director at HCL Technologies/HCL America Inc.Director at HCL Technologies/HCL America Inc.