Sam Rhee Email & Phone Number

San Marcos, Ca, Us

Washington, D.C., Us

• Provide subject matter expertise on the Veeva Systems implementation, Vault Platform, technical design, and Software as a Service (SaaS) implementation best practices• Leading business process discovery and application design workshops• Manage operational and change release activities and resources• Oversee developers and testers during the project lifecycle• Oversee requirements as part of the change management process and update (including requirements and specifications) as necessary with associated scoping activities• Assure process compliance with all regulatory and Veeva procedural requirements• Participate and contribute to process, product, or best practices initiatives• Recruit and hire employees who can contribute, grow, and drive Veeva Vault systems within JUUL Labs

Nashville, Tennessee, Us

• Successfully initiated and led the proof-of-concept workshops for the Clinical (Medical Affairs) and Commercial Operations teams by designing, configuration, and leading this project in Veeva PromoMats. By spearheading and leading this POC effort, the Revance Commercial Operations teams saved approximately $30,000 earmarked for the Veeva professional services to develop and implement the MLR (Medical, Legal, and Regulatory) workflows in PromoMats planned for 4Q2019.• Re-built the relationship with Veeva Clinical Team by re-engaging the discussion on the implementation of Veeva eTMF system at Revance. Tentatively scheduled for an on-site demo and a half-day on-site training in October, 2019. In addition, obtained an agreement to access a sandbox environment for a few weeks to properly develop the user requirements for our intended use.• Took ownership of validation activities and deployment of SAS Office Analytics that has been ongoing for last two years after joining the Revance IT R&D team.• Provided cross-functional area help by developing and writing the qualification plans and validation deliverables for IT infrastructure software such as MOVEit Automation and Transfer and Secure Desktop 10.• Provided the assistance and expertise in the SharePoint system management for the Quality Assurance and Project Management teams by co-developing SharePoint sites, configuring the notification workflows via Microsoft Flow, and building dashboards/reports via Microsoft Power BI.

Cambridge, Ma, Us

• Responsible for overseeing and managing validation activities for Veeva eTMF, Submissions and Quality Suite change managements.• Revised and executed Veeva QMS validation scripts and reviewed the traceability matrix within the first week of joining IT team to prevent delays to project timeline due to on-going resource challenges.• Amidst of QMS implementation, initiating and authoring the implementation plan to roll out business critical changes to eTMF for the first quarter of 2019.

Bridgewater, New Jersey, Us

• Manage site-level Laboratory Systems Analysts for Instrument System support teams consisting of full-time and contract technical professionals charged with supporting pharmaceutical development, manufacturing, and all aspects of quality and laboratory operations.• Developed and implemented a routine backup and restore verification for Hayward and Taiwan sites on time with limited resources to meet this vital compliance requirement for the FDA commitment.• Developed and implemented a routine system level audit trail reviews for scientific data management systems to meet the compliance requirement.• Negotiated and implemented lab system standardization with the global sites, and instituted a process to implement new instruments approved per lab system standard.• Helped to ensure the LIMS project stayed on budget by reviewing and providing capital and operational expenses report to senior management.

Foster City, Ca, Us

• Developed, implemented and validated Veeva QualityDocs as the first validated SaaS solution at Foster City within three months to share and exchange GxP data & documents with external partners (CTLs & CMOs).• Implemented and managed change management of QualityDocs system partnered/collaborated with all stakeholders (business, IT, Quality Assurance, validation team, and senior management); where successfully initiated and closed twelve change controls within the first year after go-live.• On-boarded approximately five external partners within two months by developing a process and a team to accomplish the following tasks: showcase/demo, point-of-contact identification, training & materials, and network account creation & group permission settings

Foster City, Ca, Us

• Provided technical and validation support for Scientific Data Management System (SDMS) v7.0 to v8.0 migration to upgrade the system that is no longer officially supported by the vendor.• Developed and completed the revised migration plan and migration/performance verification scripts as well as standard operating procedures to go-live with the latest SDMS system on time.• Provided support when developing global training requirements for all sites such as review of training aids and computer-based training modules to ensure that every representative from each site receives the same level of training and support from the global informatics team.• Provided support for Empower 2 to Empower 3 migration by applying a firmware patch for Waters HPLC (Alliance) systems and qualifying LAC/E boxes by running system suitability test.• Provided technical support for Empower 3 system in Amazon Workspace / WorkDocs to share and exchange research data with external partners.

Pomona, Ca, Us

• Generated and reviewed IQ / OQ / PQ protocols for GxP standalone and enterprise systems• Prepared and updated Validation Plan and Summary Report.• Reviewed User Requirements Specification, Functional Requirements Specification, and Risk Assessment documents.• Initiated and resolved deviation and discrepancy reports.

Milford, Ma, Us

• Installed NuGenesis Scientific Data Management System (SDMS) and Electronic Lab Notebook (ELN) software and executed IOQ / PQ protocols.• Executed Empower IOQ protocols.• Assisted with and/or updated User Requirements Specification and System Design Specification.• Generated and resolved deviation reports and/or associated incident reports. • Assisted customers with NuGenesis system and user / group policy configuration and design system workflows to reflect laboratory workflow.• Assessed and reviewed computerized laboratory systems to interact with NuGenesis system to capture and utilize report data and/or raw data.• Assisted in training system users and administrators.

Dublin, Ie

• Performed administrative functions (user and project management) for Waters Empower / Millennium, Agilent Chemstation, Perkin Elmer WinLab, and Malvern MasterSizer S.• Prepared and completed validation deliverables, retroactively for Empower system to address regulatory requirement.• Collaborated with QA, Computer Validation and IT to create process and close change controls and deviations pertaining to laboratory computerized systems.

Dublin, Ie

• Prepared and analyzed assay, content uniformity, chromatographic purity and stability samples as member of Quality Control group.

Dublin, Ie

• Performed performance verification and calibration for analytical instruments.• Investigated and wrote up deviation report and laboratory investigation report. • Prepared and reviewed in-house and vendor qualification protocols. • Wrote and revised SOPs and CSOPs.