Alex Dingenouts

– Supporting life science clients for digital transformation initiatives.

– Collaborated with stakeholders to assess needs, identify automation, and translate requirements into a transformation roadmap. – Led the development and delivery of scalable, compliant digital solutions, strengthening governance, operational efficiency, and regulatory alignment. – Conducted process assessments within research, facilitating workshops to document current-state processes, identify pain points, and design future-state operating models. – Owned and prioritized the product backlog based on business value, compliance impact, and risk, guiding agile teams through sprint planning and MVP delivery. – Developed and enhanced ServiceNow applications and Power BI dashboards for laboratory operations reporting. – Championed Power Apps adoption to automate key laboratory processes and drive digital innovation. – Led the RFI and vendor assessment for a QC/QA LIMS, evaluating solutions including Veeva Vault against functional, technical, and regulatory criteria.

– Optimized onboarding processes by replacing Excel-based sheets with a custom Power Apps solution, automating the end-to-end workflow from initial data capture through approval to automated TOP desk ticket creation. – Led the selection process for Document Management System (DMS) to assess RFI/RFP responses. Facilitated workshops with business to define requirements. – Developed and launched company-wide security awareness training program.

– Directed global strategy for Astellas Veeva Vaults (DMS) (eTMF, RIM, Quality). – Acted as primary liaison for the global Veeva Vault eTMF initiative, aligning Clinical Operations, QA, IT, and external vendors. Translated regulatory and business requirements into compliant system configurations, lifecycle models, and role-based authorization concepts. – Designed and implemented the global Change & Release Management framework for Astellas Veeva Vaults within R&D, establishing governance standards, release impact assessment methodology, and risk-based validation (CSV) controls. – Founded and chaired the global Change Control Board, ensuring compliant, traceable, and inspection-ready system updates across all vaults. – Led a global workstream to implement a Veeva Vault solution (in Vault eTMF) for managing Randomization Materials, including gathering user requirements, lifecycle and workflow design to support the controlled release after database lock (Lifting of the Blind). Delivered full solution design, validation, and change management to enhance compliance, efficiency, and adoption globally. – Led the RIM-to-Promomats integration initiative, creating a Single Source of Truth for shared documents. Developed cross-functional Work Instructions. – Gathered user requirements for the development of an SAE (Serious Adverse Event) Reconciliation Bot, new business process (an RPA initiative).

– Led the European archiving team across Weesp, Dijon, and Hannover, providing R&D services and improving global Trial Master files management. – Optimized global eTMF processes, replacing paper-based workflows with digital solutions while reinforcing governance and regulatory compliance. – Provided strategic oversight for audit readiness and regulatory inspections, ensuring compliance and inspection readiness across all supported sites.

– Digitized SSRB and CRC content review workflows, transforming paper-based processes into traceable systems, enhancing governance and compliance with scientific and corporate standards. – Led documentation migration projects, ensuring compliance with regulatory standards and timely delivery of validated outputs. – Supported global EDMS for compliant documentation, change control workflows, in CMC (CPD, Quality and Manufacturing), and Regulatory functions. – Supported Medical Affairs operations within the CRM platform, ensuring compliant documentation of scientific engagements, HCP interactions.