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Sr Data Compliance Lead / Learning Manager Resume Example

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SR DATA COMPLIANCE LEAD / LEARNING MANAGER
Summary

Accomplished Document Compliance Lead of site-wide learning programs, curricula design, and training metrics management. Passionate about implementing, creative solutions to complex problems. Looking to utilize expertise in project management and learning technology in GxP compliance space.

Skills
  • Advanced global learning management system administration (SAP SuccessFactors).
  • Advanced instructional design (MS PowerPoint 2016).
  • Proficient training metrics analysis (MS Power BI 2016).
  • Proficient web design (MS SharePoint 2016).
  • Proficient implementation of written standards.
  • Skilled collaboration with cross functional teams.
  • Demonstrated knowledge and application of FDA regulations.
  • Strong verbal and written communications skills.
  • Controlled document management system administration (Veeva Vault).
  • Lean Sigma white belt certification.
  • Instructional design (Articulate Studio).
Experience
Sr Data Compliance Lead / Learning ManagerMay 2015 to Current
Company Name － City, State
  • Managed 3 indirect staff in administration of training program.
  • Created periodic performance metrics measuring status of on-time training completion across manufacturing site.
  • Demonstrated leadership by Implementing Power BI dashboards for improved visibility of training compliance across manufacturing site.
  • Effectively designed new curricula to support company re-organizations, and implementation of quality systems.
  • Led continuous improvement activities for site training program. This included problem solving techniques such as process mapping and cost-time management.
  • Analyzed training data in Power BI to identify trends and make recommendations of improved performance to senior management.
  • Created site Role-based Training Program, resulting in increased productivity and compliance for over 600 personnel.
  • Developed SharePoint information hub to support training and implementation of Veeva Vault document management system.
  • Developed user friendly SharePoint site for training requests and assistance, enabling technical support for Learning Management System (LMS) issues.
  • Developed new solution in Success Factors (SAP) for tracking leavers from organization. New process streamlined activities for over 100 managers.
  • Redesigned site annual review of training using Articulate Studio, resulting in simplification and improved GxP compliance.
Sr Document Compliance Specialist /LMS AdministratorOct 2008 to May 2015
Company Name － City, State
  • Blended organization's goals and objectives with learning initiatives to deliver high-quality training program for manufacturing site.
  • Developed training materials and SOPs to enable organization's effective use of LMS.
  • Coached and trained 25 training coordinators resulting in improved training support across organization.
  • Led manufacturing site of 200 personnel in conversion from paper-based to electronic training program.
  • Administrated GxP training content, and curricula utilizing LMS.
  • Devised high quality eLearning modules using Articulate Studio.
Document Compliance SpecialistApr 2003 to Oct 2008
Company Name － City, State
  • Migrated 5000 procedures from paper to electronic document management system (EDM).
  • Managed project team of 2 contract staff to support EDM migration.
  • Led site-wide instructor-led training sessions on use of EDM.
  • Issued GMP documents (e.g. SOPs, methods, specifications, protocols/reports) through all stages of document life cycle within EDM.
  • Issued manufacturing batch records for Phase 1/2 clinical assets.
  • Redesigned process for issuance/reconciliation of controlled documents. Significantly improved traceability of GxP records in manufacturing areas.
  • Led site-wide upgrade to new electronic document management solution (CDMS).
Education
Associate of Applied Science, Web Development And DesignExpected in Jun 2023Montgomery County Community College － City, State
  • Java - Programming Concepts (January 2020)
  • HTML - Web Design and Development (July 2020)
  • Agile Scrum - Applied Software Development (September 2020)
  • Photoshop - Visual Communication (September 2020)
  • UI / UX Design (January 2021)
  • Java - Object Oriented Programming (January 2021)
Instructional Technology ManagementLa Salle University － City, State
  • Web Design and Visual Literacy (September 2014)
  • Assessment of Learning Programs (January 2015)
Bachelor of Science, General SciencePennsylvania State University － City, State

Minor: Biochemistry

Training
  • Power BI Essentials (2019); LinkedIn Learning (April 2020)
  • Migrating from Classic to Modern SharePoint Sites; LinkedIn Learning (May 2020)
  • Project Management Experience; GSK (April 2017)
  • Regulatory Inspection Trends and Data Integrity; PDA (April 2016)
  • Mastering Deviations and CAPA Management; GSK (July 2015)
  • International Training Conference; ATD (May 2012)
  • Articulate Studio; Yukon Learning (July 2011)
Accomplishments
  • Global Employee Recognition Award: Rapid implementation of new safety training in myLearning. Efforts enabled safe return of personnel to site during Covid-19 pandemic.
  • Science of Excellence Award: Defined electronic document data properties for migrating to new document management system (CDMS). Efforts allowed for knowledge-sharing within RD.
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Resume Overview

School Attended

  • Montgomery County Community College
  • La Salle University
  • Pennsylvania State University

Job Titles Held:

  • Sr Data Compliance Lead / Learning Manager
  • Sr Document Compliance Specialist /LMS Administrator
  • Document Compliance Specialist

Degrees

  • Associate of Applied Science , Web Development And Design Expected in Jun 2023
    Instructional Technology Management
    Bachelor of Science , General Science

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