Leverkusen, North Rhine-Westphalia, Germany
IT/Automation Compliance Expert with significant experience in multinational companies operating in the Pharmaceutical-Healthcare sectors. During my career I worked on Computer System Validation in pharmaceutical manufacturing (SDLC), Cloud-based IT Solutions (SaaS/PaaS), IT Compliance in the Data Migration for SAP and IT Global Investigations for IT global systems in multiple Countries (US, Canada, The Netherlands, Switzerland, France, Czech Rep). Served as a subject matter expert to project teams inside and outside the site on quality issues and participated in the development and implementation of quality methods and procedures. In order to enhance my professional profile I completed the Post Graduate Master "Cyber-Security and Data Protection" led by the Dept of Info Sciences, BioEngineering, Robotics and Systems Engineering (DIBRIS) at the University of Genoa. Skills and competences: teamworking, problem solving, communication, confidentiality, fluent English speaking.
Providing IT QA and Compliance governance on GxP IT Global Systems. Major tasks and responsibilities: • Develop and continuously adjust a Governance framework to qualify and validate Cloud-based GxP solutions (PaaS/SaaS). Support the Business Platforms in Validating IT Solutions based on recent Digital-driven technologies/processes: AI, Big Data, IIoT, Blockchain, Robotics. • Define Governance to develop quality oversight, procedures, and validation strategies for IT applications in a global environment. Authored a Global guidance on Backup and Recovery testing for Enterprise GxP IT Systems (non-ERP). • Evaluate new functionalities and assure that design meets the requirements of the Bayer QM System. • Provide regulatory guidance and decision support to project teams, Process and System Owners, as well as local quality representatives. • Approve and control the implementation of changes and validation measures; full responsibility for the QA-release of systems and changes in the context of GXP-regulations. • Collaborate and engage with Quality Management partners across Bayer Units and Chapters. • Coordination of external resources (Validation Leads). • Train project teams and site representatives on validation • Defend systems in case of regulatory audits. Acting as Corporate IT Quality Lead for the following enterprise GxP IT systems: o e-Document Management Systems: Implementation and Operational phases. o Deviations, CAPA and Complaints System: Implementation (20+k users, 60+ Countries – Quality Vault from Veeva) & Operations. o Supplier Qualification & Audit Management System (Implementation and Operational phases). o Advanced Analytics platform (PaaS) with associated Global Use Cases (Data Lakes, Deviations). o Agile developed Pilots and their scale up to Global. o Pharmacovigilance Management System and e-CTD transmission Systems o R&D Clinical systems (Adverse Event with ML/AI) and Clinical Operation System (Veeva Vault)
Headquartered in Leverkusen (GER), providing IT Compliance guidance on GxP Global Systems. Major tasks and responsibilities: • Develop and continuously adjust a framework to qualify and validate Cloud-based GxP solutions (PaaS/SaaS). Support the Corporate ITQ team on Validating IT Solutions based on the most recent Digital-driven technologies/processes: AI, Big Data, IIoT, Blockchain, Robotics, 3D printing. • Establish, drive and continuously develop quality oversight, procedures and validation strategies for IT applications in a global environment • Evaluate new functionalities and assure that design meets the requirements of the Bayer Quality Management System. • Provide regulatory guidance and decision support to project teams, Process and System Owners, as well as local quality representatives. • Conduct QA Reviews and impact analysis, approve and control the implementation of changes and validation measures; full responsibility for the QA-release of systems and changes in the context of GXP-regulations. Report continuously the quality status. • Collaborate and engage with Quality Management partners across Bayer. • Train project teams and site representatives on validation • Defend systems in case of regulatory audits. Acting as Corporate ITQ responsible for the following global systems: • e-Document Management Systems • Deviation CAPA and Complaints System (Implementation and Operational phases) • Advanced Analytics platform (PaaS) with associated Global Use Cases (Data Lakes, Deviations). • Agile developed Pilots and their scale up to Global. • Supplier Qualification & Audit Management System • Pharmacovigilance Management System • R&D Clinical systems (Adverse Event with ML/AI)
Headquartered in Leverkusen (GER), supporting the IT Compliance activities on Global Systems. Major tasks and responsibilities: • Develop and continuously adjust a framework to qualify and validate Cloud-based GxP solutions (PaaS/SaaS). • Establish, drive and continuously develop quality oversight, procedures and validation strategies for IT applications in a global environment • Evaluate new functionalities and assure that design meets the requirements of the Bayer Quality Management System. • Provide regulatory guidance and decision support to project teams, process and System owners, as well as local quality representatives. • Conduct QA Reviews and impact analysis, approve and control the implementation of changes and validation measures; full responsibility for the QA-release of systems and changes in the context of GXP-regulations. Report continuously the quality status. • Defend systems in case of regulatory audits. Acting as Corporate ITQ responsible for the following global systems: • Microbiological Environmental Monitoring System. • e-Document Management Systems. • Deviation CAPA and Complaints System (Implementation and Operational phases) • Advanced Analytics platform (PaaS) with associated Global Use Cases (Data Lakes, Deviations). • Agile developed Pilots and their scale up to Global. • Supplier Qualification & Audit Management.
Supporting the CSV function on the following major activities and projects: - IT CSV for new GxP systems - Supplier/Vendor selection and qualification for GxP comp. systems and IT services - 3P overview for IT GxP projects - Change Control + Artwork Management System + SAP SuccessFactor - Learning Management System (Cloud based application)
Head of IT Compliance Investigation Reports (IT-CIRs) for the EMEA region. Reporting directly to the Global Head for IT-CIRs, I worked for the IT Global systems on the following tasks: • On-going monitoring for incident with IT Compliance impact • Preparation and review of IT-CIRS related to GxP, Compliance and Financial Security (Identity and Access Management, Cybersecurity) • Monitoring the IT-CIRs On Time Completion process. Achieved the target (Stretch Objective) of 97% of IT-CIRS completed on time for the years 2014 to 2015 • Monitoring the CAPA On Time Completion process. Achieved the target (Stretch Objective) of 99% of CAPAs addressed by their due date • Daily teleconference with the IT-CIR team, IT-CIR owners, European Site QVC to share projects status and new initiatives • Training and coaching for the newest members in the IT-CIR team QVC (Quality Validation Compliance) responsible for Data Migration in SAP releases for the EMEA markets (Commercial Roll-Outs). I have dealt with: • Remote support to the on field QVC members • On-going monitoring for testing activities with associated deviations • Review requests for access to SAP in "Emergency Mode" (FireFighter access requests) • Master Data Change Controls (post go-live) • Live markets support in assessing the impact of the new SAP release on the local SAP instances. Reviewing Quality Assurance Plans with Site QVC • Successfully Completion of the Master Data Change Control Remediation (2008-2013) project per the plan (700+ tickets) Support the EMEA IT Hub based in Prague (CZ) in the following areas: • Building the local “IT Permanent Inspection Readiness” program • Training e coaching the local IT resources on SDLC-Computer Validation methodology, IT Risk Management, IT Compliance, IT CIR • Support validation projects based on Web technologies, Cloud, Big Data, Business Intelligence
Housed for two years (2008-2009) in the USA (Philadelphia) and, subsequently, in Canada (Montreal) and in several European Countries (Amsterdam, Paris, Lucerne) as part of the global project team for SAP deployment worldwide. Reporting directly to the Head of QVC for Data Migration, I have dealt with: o Data migration projects for SAP deployment through the US, Canada, EMEA, Singapore. - Revision and preparation of the Data Migration validation deliverables such as Validation Protocol, Data Conversion Specifications and Data Chain of Custody - Revision and pre/post approval of the validation tests (Accuracy, Extracting, Transformation, Load); Business Verification (Pre and Post Load). Variances to the validation process review. Field support to the testers - Development of a training program for testers, training and coaching new employees who joined the QVC-Migration Data team o Master Data Change Controls (post go-live).
Reporting directly to the Head of Industrial Operations and Controls, I was involved in the validation of IT systems / Automation as follows: • Quality System definition for Computerized Systems • Field automation (PLC-SCADA) in manufacturing, packaging, warehouse (MHCS/MHES), Purified Water generation/distribution, Dispensary Management System (DMS), Local Area Network (LAN), Process Analytical Technology (PAT), Chemical and Microbiology laboratories, Laboratory Information Management System (LIMS), Spreadsheets • Perspective and Retrospective Computer Validation activities: planning and coordination • Running suppliers Audit for equipment/systems (Switzerland, Germany, Italy) • Training on System Life Cycle (SLC) for Pavia/Amsterdam sites • Support the Quality Dept on Regulatory inspections (Ex. FDA, AIFA, ANVISA) • Teamworking, validation documentation review and approval • Supporting on-going validation activities: change control, config. manag., perf. monitoring • Coordinate and monitor CV group activities, assigning project work, delegating responsibility to appropriate level • Coordination of two direct resources. External resources management.