Edward Smith

Role: Collaborated cross functionally to develop, implement, and maintain quality GxP training systems and processes to meet all US, EU, and global cGxP requirements.

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Implemented change management activities, applying templated structured sponsor delivered communications and training methodology for LMS and EU CTIS deployments.

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IT LMS Business System Owner-responsible for Business requirements and Master Data for LMS to support the planning, transactional processes, and information to meet the needs of a maturing and growing organization.

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QA lead on data governance team ensuring data integrity, GCPR's, data migration solutions, and IT tool selection.

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New Hire orientation lead for GxP area and technical skill development.

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Owned, developed, and led Alector's global training program and ensured GxP programs were in a state of inspection readiness.

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Created and led the ACTS-Alector Committee on Training Strategy, cross functional team for all Alector Training/Change Management initiatives.

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Focused on people, processes (Change Management Methodology (PROSCI), Process Improvement, Knowledge Management), and Technology (LMS-Compliance Wire, Veeva, EU CTIS and SharePoint).

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Developed and maintained performance metrics, analytics, and reports.

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Inspired and fostered a strong learning culture for competencies mentoring staff for development and growth.

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Developed the enabling process, "Hire to Retire"-developed and implemented a new recruiting and interview process with HR to ensure interview teams increase the high potential candidate selection and fairness across all interview teams.

Role: Championed all recruiting and onboarding activities "beginning to end" for employee lifecycle (Hire to Retire process).

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Initiated background checks, obtaining paperwork for new hires, scheduling new hire onboarding, created, and led HR onboarding sessions, setting up new hires in BambooHR and other applicable HR systems.

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Managed offboarding (coordinating offboarding meetings, working with corporate attorney to obtain severance packages as needed, conducting exit interviews, and analyzing data.

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Recommended changes to programs and benefits to increase employee wellness, development, and retention.

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Managed resource management (driving tactical and strategic resourcing decisions and discussions, preparing for the resource management meeting while proactively looking at future landscape and opportunities for improvements for Business and Clients strategic vision and needs.

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Managed and coordinated other projects and employee development programs on behalf of HR.

Role: Responsible for the strategy, design, implementation, and effectiveness of the IT training program and all activities related to training oversight for users and usage of IT computerized systems.

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Worked to enhance Ultragenyx capabilities in IT GxP and non-GxP areas to exceed strategic, business, and financial needs.

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Lead Information Technology Change Request (ITCR's) Process/CAB Manager

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Veeva Community Group Leader for 14 key business processes

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Developed and executed IT Deviations and CAPA Management Process

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Compliance Author, Reviewer and Approver for SOP's and IT System validation scripts

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Developed and delivered IT PMO Bootcamp for ITSO, PM and BSO roles.

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Created, updated, and modified curricula according to job roles.

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Analyzed gaps and opportunities, planning, and prioritizing with IT Leadership to develop and deliver effective and measure able learning programs and solutions.

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Created a unique place to learn and work centered around: People, Process and Technology!

Role: NHO, Change Management and Process Improvement Lead

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Developed and implemented a two-day New Hire Orientation Experience (NHOE) program to better excite and equip new hires and jump start into first 30, 60, and 90 days in role.

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Led the Change Management Cohort program for entire organization via ProSci certification and methodology.

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Community (ERG) leader and sponsor; Summer intern program lead/recruiter.

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Program Manager and Developer for Ultragenyx Re-Boot Day-focus around reenergizing rituals for all employees

Role: Responsible for the strategy, design, implementation, and effectiveness of the GxP training system process and all activities of Learning Management System Tool (Compliance Wire-LMS BSO) including validation, execution, vendor audit and training SME during regulatory inspection.

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Performed needs assessment to defined LMS user requirements, tool selection, validation, and global implementation in 6 months.

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Delivered, documented, and tracked training activities per applicable SOP's.

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Developed departmental specific GxP SOP's/Standards in support of Quality System programs.

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Actively supported internal GCP audits, Health Authority inspection activities and self-audits *

Supervised up to 3 FTE including contracted resources

Dedicated my professional life in learning, creating, executing processes, and managing knowledge transfer in drug manufacturing, validation, onboarding, implementation of quality electronic systems, training management.

2012 - 2015

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On boarded 600 new hire employees generating over $3 million via ETP California State funds

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Wrote and executed, Validation Protocols, Change Controls, CAPA's, and Deviations as required. *

Drug Substance purification area technical lead for Rituxan qualification lots, TFF/HPLC expertise

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Utilized Lean Six Sigma Tools (RCA, FMEA, Charters, VOC for Biological Drug Manufacturing)

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Developed, executed, maintained training strategy and programs.

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Overseas assignment: Led training initiatives at manufacturing bacterial startup site in Singapore.

Role: Introduced fish culture and integration of agriculture as a supplemental protein source to villagers in the region, Gabon, Africa speaking French and Obumba living in a mud hut with no electricity and no running water.

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Instructed 8 fish farmers on fishpond construction, maintenance, and harvest.

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Introduced mud stove construction techniques reducing wood burning by 50%

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Instructed at schools and universities on integration of fish culture and agriculture.

Diversity and Inclusion HR Certificate | ILR School Cornell | 2018

Peace Corps, Fisheries Extension Agent Certification | University South Carolina | 1993

Bachelor of Science in Biology | S.U.N.Y. Binghamton, NY | 1989