Fabio Chiodi

System Owner for Pharma Veeva Quality Docs (VQD), Phoenix Portal, and Master Data Update Tool

Achievements:

• ASPIRE Certificate and Batch Master integration
• ASPIRE BRH check interface
• Clinical RMT implementation into VQD
• Continuous improvement of VQD covering PT and PD Business requirements
• Continuous improvement of Phoenix Portal covering PT and PD Business requirements
• ASPIRE DIA Doc integration into Phoenix Portal
• Implementation of 360 Quality Analytics solution into Phoenix Portal
• eValRoche integration into Phoenix Portal
• Resource management for assigned contractors

By

• Fostered positive work atmosphere to enhance team morale and productivity.
• Established and maintained quality control standards to improve customer experiences.
• Addressed and resolved conflicts effectively to ensure positive work environment.
• Distributed responsibilities among staff to foster teamwork and efficiency.
• Oversaw daily business operations to maintain efficiency and operational success.
• Cultivated strong partnerships with stakeholders to support business objectives.
• Led team meetings to foster open communication and collaboration.

• Streamlined production process by identifying and eliminating inefficiencies.
• Built high-performing team.
• Negotiated contracts with suppliers, reduced operational costs.
• Led cross-functional team for successful product launch.
• Managed strategic TechOps Quality projects and communicated findings to stakeholders.

• Managed and led the Business Analyst team in the Pharma TechOps Quality area, providing coaching, mentorship, and professional development support to team members.
• Conducted recruitment interviews for new team members and strategically assigned resources to key projects.
• Served as Pharma TechOps Quality Resourcing Coordinator, ensuring optimal alignment of team members with high-impact initiatives.
• Facilitated interactive activities during quarterly All-Hands sessions to foster global collaboration and strengthen interpersonal connections across diverse teams.

Lead Business Analyst – Pharma TechOps Quality

• Oversaw all Veeva QualityDocs (VQD) Business Analyst activities, driving success through strategic leadership and execution.
• Implemented agile user story management process to enhance development efficiency and team collaboration.
• Acted as a Pharma TechOps Quality Domain Expert, documenting requirements for complex integrations with 3rd-party systems like the Roche Master Data Management System and SAP.
• Mentored and developed Business Analysts, elevating team expertise and competencies.
• Designed and implemented Request for Change process to streamline change and incident management post go-live.
• Defined and introduced Roche Product Identification standard for consistent usage across all Veeva Vaults (Quality, Regulatory, and Clinical).
• Supported the Phoenix project by successfully integrating GxP-compliant Quality content management systems, such as GMP SharePoint and Project Library, into Veeva QualityDocs.

• SPECA Hybrid Project: Successfully planned and delivered a global project to refactor and migrate the legacy SPECA application within scope, budget, and timeline. Designed and implemented a scalable and validated hybrid solution to optimize QC analytical processes, introduced an intuitive specification library, and established a validated SingleLIMS interface to enhance the medicinal product certification process. Oversaw release requirements, change management, and knowledge transfer during the hyper care and transition phases.
• MELODI@KAU FINP & HTO: Managed the refactoring and phased implementation of the QA batch release system, MELODI V2, ensuring successful delivery within budget and timelines. Conducted fit-gap analysis, directed implementation at KAU FINP and HTO, and oversaw the validated integration with key systems such as KAU MES, Genentech SAP, and GBT. Enhanced operational efficiency with an intuitive user interface and a Quality Compliance Check dashboard for streamlined business processes.
• QCS (Quality Compliance Scorecard) V2: Spearheaded the global refactor and rollout of the QCS solution to Basel and SSF in a validated environment, ensuring on-time and on-budget delivery. Conducted process gap analysis to implement efficient workflows, aligning the solution with business needs. Sustained compliance and improved the user experience through effective post-implementation support.
• PD LMS to Cornerstone Migration & Decommission: Delivered project milestones by supporting the transition from PD LMS to Cornerstone and leading the decommissioning of the legacy PD LMS system, ensuring timely and cost-effective execution.
• ePRISM (Preparation and Readiness for InspectionS Management): Led the implementation of one of the first cloud-based solutions to streamline inspection management preparation in Pharma Development, including full SSO integration and ensuring timely and cost-effective execution.