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Senior Manager Resume Example

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SENIOR MANAGER
Summary
Technical Proficiencies Tools Veeva Systems | Oracle Argus Safety | ServiceNow | ComplianceWire | DocuSign | PleaseReview | SmartSheet | MasterControl | Pilgrim SmartSolve | CATSWeb | Microsoft Dynamics AX - ERP| Microsoft Dynamics CRM | SharePoint | Oracle Taleo | Salesforce | Pervasive Data Integrator | MS Applications | SAP | TrackWise | QUMAS | AutoCAD | Crystal Report | Oracle Fusion | Validation Master | Office 365
Skills
  • Senior IT Systems Leader
  • Excels at implementing and managing major complex global GxP/Non-GxP information solutions
  • Dynamic, technically sophisticated leader with expertise in business solution implementation, project management, budget/resource planning, regulatory compliance, and cross-functional collaboration. Over 15 years of hands-on experience in various IT roles. Proven ability to drive SaaS and Hosted platform system projects from conception to completion. Excels in system validation knowledge such as IQ/OQ/PQ. Proficient in maintain strict compliance with rigorous quality standards, including GxP, GAMP 5, and FDA 21 CFR Part 11. Strong team leadership, personable and engaging with the communication skills needed to build consensus on critical initiatives.
  • Subject Matter Expertise
  • Systems Development Life Cycle
  • Budget/Resource Planning
  • Cross Functional Leadership
  • Computer System Validation
  • System Release Management
  • Learning Management Systems
  • Pharmacovigilance
  • Quality Management Systems
  • Portfolio Management
  • System Integration Analysis
  • System Change Management
  • Vendor Management
  • Data Migration
  • Agile Scrum Methodology
  • Pharmacovigilance
  • Data Quality/Integrity
  • Application Support
  • System Architectural Design
  • Data Analysis and Management
  • Disaster Recovery/Business Continuity
  • 21 CFR Part 11, Delivery, Processes, System Integration
  • Agile, Disaster Recovery, Project management, Technical analysis
  • Architectural Design, ERP, Project plans, Upgrade
  • Articulate, Senior management, Quality, Validation
  • Agency, Functional, Quality Assurance, Vendor Management
  • Benefits, GAMP 5, Quality Management
  • Budget, Gateway, Reporting
  • Business process, IQ, Requirement
  • Change Management, ISO, Requirements gathering
  • Communication skills, Team leadership, Safety
  • Consultant, Leadership, SDLC
  • Continuous improvement, Managing, Software development
  • Council, Meetings, SQL Server
  • CRM, OQ, Stories
  • Data Analysis, Oracle, System design
  • Data Migration, PQ, Systems Development
Experience
Company Name | City, StateSenior Manager01/2019 - Current
  • Orchestrate global IT systems with ownership of the Veeva Vault Quality Suite, Oracle Argus Safety and DocuSign.
  • Drive seamless coordination and effective communication across multiple managed service providers.
  • Articulate technical system design considerations, trade-offs, benefits, and recommendations for technical architectures based on business requirements.
  • Drive end-to-end system development lifecycle to ensure delivery of highly scalable, secure, and robust solutions optimized for business needs.
  • Leverage Systems Development Life Cycle (SDLC) methodology to implement systems in partnership with various business-functional teams and managed service providers.
  • Lead and manage tier-level of system support requests with internal end user service team and external manage service providers.
  • Lead and facilitate quarterly based business review meetings with senior management team as well as systems architectural design review sessions including disaster recovery, business continuity and IT governance best practices.
  • Drove major project implementation of Veeva Vault Quality systems in 3 phases including major system enhancements, system releases and decommissioning of paper-based quality systems.
  • Delivered multiple concurrent projects: mandatory major system upgrade and reporting submission gateway project for Oracle Argus Safety system to fulfill agency report submission requirements.
  • Took system ownership of DocuSign and maintain system's GxP compliance requirements.
Company Name | City, StateSenior Business Systems Analyst01/2015 - 01/2019
  • Drove multiple midsize global Quality Management System projects from start to finish.
  • Established best practices and scaled across the organization.
  • Leveraged PMP principles to enhance efficiency and meet aggressive schedules.
  • Managed and led ERP quality modules/QMS project for development, creation, and modification of Standard Operating Procedures, work instructions, and templates.
  • Partnered with Quality Assurance and business functional teams for all validated GxP system projects.
  • Drove MS CRM system enhancements projects and new module implementation.
  • Took concurrent system ownership of MS AX ERP GxP quality modules and MS CRM system.
  • Drove all GxP related activities including requirement gathering and validation testing for QMS and ERP.
  • Defined best practices for 21 CFR Part 11 and cGxP Computer Systems Validation.
Company Name | City, StateSenior Business Systems Analyst01/2011 - 01/2015
  • Conducted detailed business and technical analysis to identify performance gaps and drive business process improvements to enhance operations.
  • Served as primary point-of-contact with consultant companies to utilize ERP system validation in support of quality deliverables including System Validation Plan/Report, User Acceptance Test, Use Cases, User Stories, Test Report, and Requirement Trace Matrix.
  • Defined project charters, identified stakeholders, and created project plans.
  • Delivered all aspects of the software development life cycle for QMS SQL Server Reporting Services (SSRS) report project, including requirements gathering and validation, test plan creation, and test coordination.
  • Championed continuous improvement (CI) culture in accordance with IT change control best practices.
Company Name | City, StateBusiness Systems Analyst01/2007 - 01/2010
  • Facilitated optimal utilization of CATSWeb-compliant module architecture, analysis, design, development, testing, and configuration.
  • Delivered thorough evaluation of change requests regarding system validation deliverables.
  • Delivered continuous enhancements to CATSWeb system to improve the end-user experience.
Company Name | City, StateQuality Systems Analyst I01/2005 - 01/2007
  • Contributed to the divisional quality system to ensure compliance with regulatory standards, including FDA QSR, EU Council Directives 93/42/EEC, ISO 13485:2003, and CMDR.
  • Effectively managed the maintenance of VIACK repository and served as liaison in developing framework outlining an efficient management system of business-related processes and best practices.
  • Demonstrated expertise in using QUMAS for the application of document control system.
Education and Training
Boston University | City, StateMaster of Science in Computer Information Systems
Northeastern University | City, StateBachelor of Science in Business Administration, Management Information SystemsAccomplishments and Honors Agios Competency Triumph (ACT) Award – Agios Pharmaceuticals 2020 Employee Performance Recognition Award – Sekisui Diagnostics 2018
Certifications
Project Management Professional Certification (PMP) Certified Business Analyst Professional (CBAP) International Software Testing Qualifications Board (ISTQB) Foundation Level Certification
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Resume Overview

School Attended

  • Boston University
  • Northeastern University

Job Titles Held:

  • Senior Manager
  • Senior Business Systems Analyst
  • Business Systems Analyst
  • Quality Systems Analyst I

Degrees

  • Master of Science in Computer Information Systems
    Bachelor of Science in Business Administration, Management Information Systems

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