Madrid, Community of Madrid, Spain
Compliance & Quality Management in the Healthcare Sector (Pharma, Medical Devices, Diagnostics & Health IT) in multi-language and global environment.
Supporting the Digital Transformation of QA Processes in ALK, I leverage my previous experience in the Pharma sector by connecting the dots of my earlier roles of IT, QA and CSV / Validation Professional with this IT Solution Architect Role. Technically I support Veeva Vault implementation projects with solution design, implementation, validation and testing activities. Currently I am integrating Veeva QualityDocs with Adobe Acrobat Sign. My previous QA and Validation experience allows me to have direct and efficient dialogues with QA and streamline compliance activities. I'm also directly responsible for inspection readiness. As a senior professional I lead technical project tracks coordinating teams and directly supporting the project manager with budget estimates, planning and tracking. I also provide crucial support to the operations team with expert advice for system maintenance and PowerShell API scripting for exceptional data handling. I'm very good at doing magic with Excel and Excel PowerQuery to provide insights in project or system data and do advanced data management. Ad interim I also fulfilled the role of Release Manager and contributed to the ALK Agile transformation using Azure DevOps.
Ensuring GxP compliance of the Global SAP solution.
Regulatory compliance and quality management of Health Informatics Electronic Medical Record (EMR) solutions.
Reporting to the Site Quality Head in the Small Molecules Galenical Plant in Leganés Certified by Roche Quality Certification Program Main responsibilities: -8 direct reports -Responsible for the Pharmaceutical Quality Management System and the operation of its core processes -Accountable for the GMP compliance of all exporting countries including Europa, USA & Japan -Implementation of the global quality processes and its supporting IT systems (e.g. TrackWise). -Facilitator of Quality Risk Management activities
Global Informatics Quality Main responsibilities: -IT Quality Assurance in large global IT Infrastructure projects -Ensure ITIL, CSV & GxP compliance
Group Infrastructure - Shared Services Support Main responsibilities: -3 direct reports -Responsible for operational support of the HP Service Desk platform -IT Governance of the global infrastructure middleware services department -ITIL Expert
Main responsibilities: -Lead consultant in large software testing projects
Main responsibilities -Course development on project quality management -Website development