Richard Diaz Email & Phone Number

Huntington Beach, Ca, Us

Santa Barbara, Ca, Us

Contracted to Gilead• Led the successful upgrade of Gilead’s 900+ user Biovia Notebook ELN system from version 2019 to 2023. This facilitated continued vendor support and provided user relief to critical issues. The project incorporated over 15 site leads and process owners. In addition, over 100 customizations were tracked, rebuilt, and tested.• Project-managed various ELN enhancements and integrations, such as LabX and NuGenesis, and various spreadsheet conversions for improved end-user efficiency and a disaster recovery implementation. • Implemented the use of Microsoft’s Project for the Web tracking of projects, roadmaps, and critical tasks. This facilitated greater visibility to leadership and task owners by providing specific metrics and reminders tailored to individual needs. • Supported ELN Management in the development of project roadmaps by working with business units, business analysts, and developers to provide estimated project resources, timelines, and costs.• Collected ELN performance metrics and trending data to report in quarterly operations meetings. Worked with administrators and developers to analyze trends and develop paths for issue remediation.

San Rafael, Ca, Us

• Member of the Technical Operations (TOPS) Business Technology Committee that reviews and develops the ~$15M annual IT project portfolio including budgets and resources. This group is responsible for most technology spend across Manufacturing, Labs, Facilities, and Engineering.• Responsible for project and program delivery frameworks and processes, and the overall implementation of technology objectives for the TOPS organization.• Managed a 10+ TOPS PM team which consisted of both internal staff and consultant to ensure consistency in deployment, financial and delivery reporting.• Developed and maintained training for PMs on BioMarin IT tools such as Planview PPMPro, and TOPS specific one such as Oracle OPPM and P6. Conducted monthly audits to ensure consistent delivery process among all PMs.• Led an international SoftMax Pro Server and workstation upgrade project to meet a critical regulatory commitment. Project included data migration, workstation decommissioning and AWS disaster recovery.• Directly led other initiatives to meet compliance and/or manufacturing objectives such as Scientific Platforms Software Inventory Library, validation of various lab instruments, CMMS updates, and facility expansions.• Oversaw the implementation of a new multi-year QC instrument program leading to reduction validation timelines from an average of 224 to 84 days and delivering a cost savings of over $4M.• Supported the rollout of Benchling, a modern ELN system, that was implemented across two geographic locations and 200 users which allowed standardized templates with consistent auditability and risk reduction.

San Rafael, Ca, Us

• Project Manager responsible for supporting multiple departments in R&D and Clinical.• Developed work and resource plans, schedules, and managed budgets.• Led the team in the implementation of a High-Performance Computing environment utilizing Bright Computing Cluster Management Software.• Led the development of a new Medical Information Request iOS and Win 8/10 app that allows field staff to make efficient and compliant requests. The solution removed impediments such as the management, storing, and transmittal of paper forms and increased response times by over 50%.• Upgraded the Adverse Events (AEs) iOS and Win 8/10 applications by utilizing Microsoft Flow, an SFTP Server, and Axway gateway. This allowed AEs to be directly ingested into Argus Safety as an ICH E2B R2 Message ensuring that critical regulatory reporting requirements were met.• Managed the Liquent Insight 6.1 and Axway upgrade to meet the EU eCTD M1 3.0 to ensure reporting continuity. Project was performed under extremely compressed timelines due to the vendors late delivery of compatible software and the EU’s timeline to transition from 2.0.• Led corporate wide DocuSign for Part 11 eSignatures implementation that automated a manual “wet signature” process and expanded it to allow any BioMarin group to easily route/sign compliant documents.

London, Gb

Contracted to BioMarin Pharmaceuticals - Project Manager for TrackWise Deviation/CAPA system for Development Sciences Quality Group. This project consist of five new GCP workflows and associated business processes.

Hayward, Ca, Us

• Managed the Quality and R&D application team which consisted of six project managers, business analysts and validation engineers.• Partnered with the business to shape vision and drive delivery excellence. Ensured solutions solved business needs and were completed within the approved program budget and schedule. • Oversaw internal validation and project management resources in the implementation of a SaaS model Argus Safety Pharmacovigilance system. Directly owned several aspects of the project including budget, status meetings, and resource and vendor management.• Owned the implementation of a Global Change Control system based on TrackWise with 350 users. Completed on time, under budget and included the involvement of over 60 stakeholders to ensure a successful launch. • Met with senior business leaders to develop system roadmaps, project initiation documents and evaluated solutions for critical business needs such as Publishing, Regulatory Information Management and Content Management.

Dublin, Coolock, Ie

• Senior manager responsible for overseeing the quality systems application group which consisted of up to 14 business analysts, developers and administrators supporting 6,000 users across 12 sites in the areas of Content Management, Metrology, Quality Management, Manufacturing and Laboratory systems.• Led monthly Quality Working Group meetings with senior business and IT representatives to identify, develop and execute business strategies to improve quality operations and report progress of current initiatives. • Led teams in collaboration with corporate and site quality leadership to facilitate the expansion of TrackWise Quality Management system to our Malta, UK, Northern Ireland and India locations which included Training Management, Change Control, CAPA, Investigations, Auditing and Customer Complaint business processes.• Responsible for broad range of management activities such as program and project management, multi-tier application support, performance metric reporting, staff coaching and reviews.• Worked with Corporate Quality Assurance and Validation leadership to develop a risk-based strategy for evaluating and testing patches that leveraged existing operation qualifications and DIAL scripts to considerably reduce time tables and costs associated with system upgrades and improvements.• Leveraged existing technologies and business process improvements to develop new frameworks to support and align to company’s aggressive growth by acquisition business model which resulted in a tripling of user counts with no additional overtime or staffing increase. • Partnered with business executives and IT leadership to develop company-wide quality systems application portfolio review, scoring and rationalization process that led to the formulation and execution of a multi-year strategic road map.• Led portfolio reduction initiatives for SLIM (Stability) and Qumas DocCompliance systems leading to an annual savings of $300,000.

Dublin, Coolock, Ie

• Implemented the company’s first SDMS Water’s NuGenesis system utilizing 5 different classes of lab instrumentation providing the company an auditable part 11 complaint process for backing up and managing critical R&D data.• Completed major overhaul of Lotus Notes Domino infrastructure which consisted of high availability regionalized solution using AIX servers resulting in increased reliability and $550k savings over 3 years.• Oversaw the final two major phases of Watson’s LabWare LIMS implementation which consisted of Environmental Monitoring and Stability modules.• Functionally aligned a disparate application group by business areas to facilitate improved strategy management, higher service levels, and mitigate risks.• Implemented a 5 site Calman Enterprise system leading to process standardization and increase in compliance within metrology groups.