With 20 years of software implementation experience, I am confident that I can add value to any project or change management effort through the use of SDLC waterfall or Agile SCRUM methodologies. The experience I have gained in the last 12 years is dedicated to Quality processes and the 21 CFR Part 11 QMS solutions needed to follow FDA regulations in the Pharmaceutical, Medical Device, Consumer Products, and Oil&Gas Industries. The specific QMS solutions implemented are Sparta Systems’ TrackWise and Veeva Systems’ Vault (QualityDocs, Vault QMS, Promomats, RIM, and eTMF). I am a confident and knowledgeable implementor with strong technical problem-solving skills and system understanding as a seasoned globally traveling consultant. The size range of clients serviced ranges from small local pharma companies of a single business unit to a global multi-site/country implementation. • As a seasoned consultant, I understand and adhere to corporate standards regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance, data security, software validation, and the SDLC• Extensive experience in global QMS implementations mainly for Pharma and Medical Device• Leader and mentor for SDLC and AGILE methodologies with SCRUM Master experience• Proficient use of the following job role support applications:Jira Confluence MS Project Primavera Documentum SharePoint• Implemented new TrackWise instances for the following processes:Global Change Control Complaints Deviations Investigations CAPAs OOS/OOT Audits Safety Observations Effectiveness Checks Service Cases eMDR Clinical Trials Training Management Commitment Tracking Logistics EH&S• Highly proficient QMS solution consultant experience specific to the following roles: Project Management / Business Analyst / Configuration Specialist / Technical SME

Implementing QMS solutions for the Medical Device Industry.

Eckhart Consulting offers resources for implementation of TrackWise eQMS and Veeva Vault software solutions. We currently offer our knowledge and experience to major Pharmaceutical and Medical Device customers in the following process areas: Audits, Change Control, Complaints, Deviations, eMDR submission, Investigations, Safety Observations and Laboratory Sample Management. We also offer experience in the documentation of validated systems, requirements gathering, Crystal Reports/Business Objects reporting, and software validation services.

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready eQMS and Compliance processes, enabling customers to deploy quickly and cost effectively.

Maintained 100%+ billable utilization as a full time Sparta employee, $500,000+ in services revenue per year as a Delivery Analyst while also fulfilling many internal Sparta department responsibilitiesMentored, trained, and empowered 22 TrackWise consultants while in the Senior Analyst role by developing an on-boarding process using classroom instruction, SDLC experience development (shadowing, exercise/practicum, presentations), Technical Leadership, Independent modeling and Team/Network knowledge Baselining with a focus on support and innovation Managed team of 8 remote consultants with an average yearly team utilization of over 85% billing – • Scheduled resources for customer engagements to maximize utilization and downtime• Resolved and escalated issues to/from resources, clients, mgmt or support teamDeveloped Certification Program for TrackWise Admins

Customer Engagement Manager/Project Manager 2013….2014Charles River Charleston, SC Upgrade/Complaint ConfigurationAltria Richmond, VA Discovery/Technical SME/Change Control projectLead Senior Solution Delivery Analyst 2011….2014Merck Whitehouse, NJ Upgrade (8.5)/MMD/Risk Assessment Pfizer Peapack, NJ Upgrade/gQTS (global TW)/ConfigurationAbbott Labs Abbott Park, IL Technical SME/Issue Resolution/TW SupportGalbraith Labs Knoxville TN Upgrade (8.2)/Documentation/Re-Key effortSenior Solution Delivery Analyst 2009….2011Watson Pharma Corona, CA Validation Re-Key/Complaint/Tech SMEGE HealthCare Wauwatosa, WI eMDR/Tech BA/Configuration/FDA BABoehringer Ingelheim Mexico City, MX Complaint/CAPA/Reporting/ConfigBaxter HealthCare Vernon Hills, IL global Audit/Tech BA/Reporting/ConfigStryker Instruments Kalamazoo, MI global Audit/Tech BA/Reporting/Config/CBTCherokee Pharma Danville, PA Upgrade/Tech SME/Archiving/Data MigrationBP Oil Anchorage, AK Safety Observations/Tech SME/Tech BASolution Delivery Analyst 2007….2009Bristol Meyers Squib Plainfield, NJ Tech BA/Risk Assessment/Upgrade AnalysisIntegra life Sciences Plainsboro, NJ Tech SME/CBT/Complaint and CAPASolvay Pharmaceuticals Marietta, GA Tech SME/Support Desk/Change ControlICU Medical Salt Lake City, UT Complaint/CAPA/Tech SMECalypso Medical Seattle, WA Tech SME/Service Case/Complaint/CAPASanofi-Aventis Bridgewater, NJ Tech SME/CBT/Reporting/TranslationsMedImmune Frederick, MD Tech SME/Complaint/CBTCustomer Support 2007….2007

Project: Implementation of an ERP based solution (Enterprise One integrated with BuilPro/Primevera Scheduling software) across all divisions to standardize SOPs and to meet Sarbanes-Oxley compliance.Created system models using Rational Requisite Pro to evaluate processes and requirementsDetermined scheduling methodologies (CPM, Milestones) for a software driven high volume housing production building processOwned the Change Management process and Communication Plan between Mgmt, Users, Implementation Team and stakeholders relating to high priority issues and upcoming Change PlanDeveloped training materials and certification curriculum for trainers, admins and end usersOversaw implementation of scheduling solution throughout California region (65 Communities)Set up a 3-tiered platform for system issue escalation for Corporate IT Support Desk.Analyzed the use of new wireless tablets and various PDA technologies to identify application use viability for end user experience. Conducted presentations and Demos of application solution to division executives as part of Implementation plan

Implemented job tracking and tooling inventory control application using Microsoft Access to streamline production from paper-based process and allowed for real time business level reporting for management and staff in purchasing, production, quality, warehouse, and salesDocumented company policies and procedures for the upgrade of plant facilities to ISO 9001:2000 to meet client requirements for their industry standards. Over 60% of total production required these standards and audited annually.