Edward Everett Email & Phone Number

Eastpoint, Fl, Us

Fremont, California, Us

Provide IT Project Management for Pharmaceutical Manufacturing.

For GMP Systems, performed data integrity assessments and created/updated Admin SOPs. Identified supplemental CSV for applications.

Managed Quality oversight for IT System implementations requiring GxP Validation. Organized, reviewed, and approved CSV artifacts. Provided guidance on regulatory requirements. Created Policies and SOPs to support a robust CSV process.Managed a Data Integrity project for a Biotech client. Performed an assessment of all systems and end-to-end data flows in QA, QC Lab, Production/Manufacturing, Distribution, and Engineering. Identified gaps in data integrity and proposed various technical and procedural controls as remediation. (21 CFR Parts 11, 58, 210, 211, 312, 600) (cGMP, GxP) Created Policies, SOPs, and Templates to support a GMP environment. Provided guidance on Regulatory inspections.

Managed projects for Digital Asset/Content Management applications. Work performed in an Agile/Scrum framework following SDLC methodology.

As a consultant to GSK, Managed the schedule and activities for a pharmaceutical manufacturing and distribution site ownership transfer. Managed workstream timelines for IT, Quality, Engineering, Supply Chain, HR, and others. Needed to ensure GxP documentation was created, re-branded, or obsoleted. Worked with new ownership to dovetail restart activities with shutdown activities.

As a consultant to AstraZeneca, I was responsible for delivering Big Data projects for Commercial Marketing into a Cloudera (Hadoop) instance hosted in the Amazon VPC cloud. The team I managed was a mix of on-shore and off-shore resources comprised of Business Analysts, Solution Architects, Developers, and Testers. Data was sourced from Veeva, Salesforce.com, and third party providers. It was ingested into Cloudera and prepared for analytics in MicroStrategy. I utilized ServiceNow for Change Management, Service Requests, and Incidents. Jira was used to capture features and bugs and project documentation was maintained in Confluence.

As a consultant to J&J, I managed a ~$7 Million implementation of Planisware following an Agile Scrum approach. The project followed the J&J SDLC and PMx standards. This Project and Portfolio Management (PPM) system will provide a single source of truth across Medical Devices for J&J. I worked with the vendor to map their release plan into the overall project schedule. I worked with the business to align User Acceptance Training (UAT) and End User Training with the planned releases. Project management tools utilized were MS Project 2016, MS Project Server 2016, SharePoint 365, and MS Office 365.

As a consultant to J&J, I managed a GxP validated implementation of Salesforce in the Global Consumer Care organization. This global application includes Service Cloud and Marketing Cloud as well as third party apps. I organized and coordinated activities between multiple workstreams including IT development, change management, application support, and business processes. I tracked and updated activities using the project schedule that I created during the planning phase of the project. Metrics were then generated and communicated for review in a project dashboard. Overall development follows an Agile SDLC track with GxP validation deliverables. I'm managed the global implementation using a regional release schedule. I planned, scheduled, and facilitated Project Sponsor, Steering Committee, and Core Team meetings and performed any identified follow-ups to keep people connected and informed. On a monthly basis, I met with the finance team to review the budget and invoices processed to ensure we stay on track financially and identify the need to escalate awareness of budget concerns. The global scope of the application requires that I ensured adequate inclusion of all regional SMEs in discussions relevant to the final platform. This is approximately a $10 Million effort.I provided oversight and direction of a new CRM implementation in Global Consumer Care. In addition to managing the vendor selection process, I created the Project Charter and a Capital Appropriation Request (CAR). I created the project schedule in MS Project Server which is under a PMO framework (PMx). I reported progress and status using a dashboard/scorecard system. I facilitated the meetings between the business and IT to create the organizational support model for the project and post-deployment support.

As a consultant to Ethicon Endo Surgery (J&J), I provided program management consulting services to the Labeling Center of Excellence. The current program is an implementation of a new execution process for labeling of medical devices (21 CFR part 820). In addition to managing program governance, I handled issue escalations from the project managers for the various pilot projects during the monitoring phase of the implementation. I drove the launch of a new metrics reporting tool for the project portfolio as well as created monthly status slides for communication to the Executive Council. I instilled a sense of urgency in team members to meet aggressive deadlines.

At Ethicon (J&J), I provided program and project management consulting services for Quality, Regulatory, and Compliance programs/projects for medical devices (21 CFR part 820). Provided project management guidance for a Quality Systems Integration effort. Facilitated the monthly status slide updates across 12 work streams and prepared for management review. Established a SharePoint site for managing issues, risks, action items, documents, and dashboard. Developed Visio diagram to illustrate demand management challenges of implementing Regulatory changes in a competing time-frame.

Provided Project Management leadership for re-validation effort on numerous GxP systems in support of Medical Devices and Diagnostics. Harmonize existing applications with client's SDLC producing validation documentation set as an output following GAMP 5 approach. Ensure 21 CFR Part 11 and Part 820 requirements are met.Managed re-validation and testing of Manufacturing and Distribution Systems such as dcLINK from DSI and Pick to Light from Dematic. Leading re-validating of custom software application for RFID system.Managed in excess of 12 projects simultaneously with different project teams while ensuring risks and issues are raised to the correct level.Provided weekly status updates via SharePoint and MS Project Server in addition to in-person presentations to governance committee.

Atlanta, Georgia, Us

Scrum Master for Clinical Data Analytics projects. Facilitate planned releases according to the Release Plan for the organization. Implement a workable scrum framework.Program Manager for Clinical IT projects at a pharmaceutical client. Managed projects to migrate Clinical solutions/data to a new AWS big data architecture for improved Analytics.Managed projects to implement Covance Xcellerate application and create data hub from client source systems.

April 2011 - January 2014: Service Lead, Safety & Regulatory Book of BusinessLed, managed, and coached a global team of 22 onshore and offshore resources in operations and support of Book of Business activities for Global Safety, Compliance, and Office of Chief Medical Officer. Supported activities include adverse event reporting, compliance, audits and inspections, clinical literature archive, and ICSR E2B (21 CFR parts 11, 210, 211). Supported applications include Oracle Argus Safety Suite and Empirica Signal. Employed Six Sigma methodologies to improve processes and reduce costs. Ensured regulated applications remain GxP compliant. Provided guidance and direction for migrating legacy safety applications to Oracle Argus Safety Suite. Provided Service Transition roadmap and developed corresponding SOPs and Job Aids. Implement ITIL processes for service delivery.May 2010 - March 2011: Business Analyst ManagerProvided leadership and mentoring to a group of business analysts in support of two global safety systems: one custom system and the other based on Oracle AERS.

New York, New York, Us

Defined and implemented IT strategy for Clinical, Safety, and Reporting (R&D IT) (21 CFR parts 11, 210, 211). Focus areas of Global Pharmacovigilance and Adverse Event / Safety Reporting. Successfully implemented offshore development model with onshore support. Additional responsibility of driving Clinical R&D projects to successful completion. Consistently delivering critical projects on or ahead of schedule. Developed, implemented, and tested Disaster Recovery Plans and Business Continuity Plans for Pharma Research. Identified and implemented process improvements to the Software Development Lifecycle (SDLC). Developed and implemented Global R&D IT support model.

Forchheim, De

Managed multiple software and IT projects for multi-million dollar, internet-based, healthcare information system.

Consultant in software development for intranet and internet applications with the largest clients being FirstUSA, GlaxoSmithKline, and Siemens Medical Solutions. Development was iterative and RAD primarily using Java (J2EE) and Oracle.

M.S., Computer Science

Software Security Foundations Certificate, Software Security

B.S., Math