Leading IT implementation activities in Analytical Research & Development (ARD) Operations CH. Collaborating in global ARD initiatives in data & digital strategies and systems. Chairing the Process Automation network in the cross-line functional New Chemical Entities organisation. Super User of ARD Business Process maps applying BPMN2.0 tools.

Driving and defining the design and implementation of Clinical Processes & Innovation (CP&I) owned and supported continuous improvement projects and initiatives, with focus on current tools, systems and processes in collaboration with Global Development Quality (GDQ) and Global Drug Development (GDD).Global GDQ Lead in the Novartis Quality Innovation Hub; overseeing innovation and digital/technology projects.Global GDD Functional Representative for the Quality System "Data and Document Management". Representing global GDQ in innovative projects (eg digital QMS tool) led by Novartis global QA.Defining and reporting metrics (KQIs/KPIs).

Global Lead in the Global Development Quality and Quality Management Systems (QMS) Department leading/supporting projects and governance activities for GMP, GCP and PV areas. - Leading cross functional Teams of Global Drug Development (GDD) and Global Development Quality (GDQ) representatives to ensure continuous improvement of the governing Quality Management System processes and Technology solutions.- Leading global Workstreams in digital QMS Projects. Applying agile methodologies/tools such as Scrum, Blueprint, JIRA/Confluence. Contributing to ML/NLP activities. Hackathons and internal networks eg Blockchain.- Representing GDQ in QA IT governance boards/councils and System migration Projects.- Developing and Monitoring QMS metrics in close collaboration with GDQ compliance for process and technology projects.- Identifying risk-based QMS continuous improvements initiatives to ensure ongoing compliance of Quality Management Systems in Development with global HA requirements and Novartis Quality Standards-- Collaborating with Corporate Quality, Internal IT, IT vendors, GDD and GDQ QMS unctional leads to ensure robust QMS technologies are in place.- Support annual Quality planning on GDQ QMS Level, owning and defining activities/Actions to drive Quality Performance across GxPs.- System Owner of a supportive SOP and process search IT system. - Supporting cross-functional Quality Manual implementation and global SOP Review and overall governance activities- global Key User and Contributor in documentation systems.

Activities and responsibilities as below (Quality Senior Manager) but with more focus on project work, ie leading and contributing to global, innovative projects in TRD (e.g. SOP simplification; owning supportive SOP full-text search tool; implementation of a validated document management system).

Leading the global/local implementation of the Novartis Quality Manual in TRD with CAPA monitoring and reporting.Central expertise, responsibility and ownership of selected QA processes and for SOP related activities:- expertise and guidance in developing process maps (BPM tool), SOP reduction/alignment and defining standards for effective SOP writing.- Process owner of selected Quality System processes.- Holding roles as Key User, SOP manager, author, reviewer, approver, printer.Representing global TRD/TRD-QA in cross-functional Development and Pharma boards and leading other activities such as the Site Quality Risk Assessment trainings. Audit/inspection supporting and global TRD single point of contact of the Novartis cross-divisional Pharmacopoeia desk.

Laboratory head (Senior Investigator I) in the Biotransformation (BT) section in the Drug Metabolism and Pharmacokinetics (DMPK) department, Novartis Institutes of Biomedical Research.- Planning of in-vitro and in-vivo (ADME) radiotracer studies to quantify and elucidate the structure of metabolites, to identify metabolic and elimination pathways and to calculate PK parameters. The analysis is performed by using analytical techniques such as ToF-MS/MS, HPLC-UV and radiodetection, TopCounting and LSC.- Leading up to 3 lab associates including training and performance assessment and objective setting. Interviewing and selecting new BT associates- Responsible for the writing of registration relevant reports and publishing in internal databases. Scientific data assessment of pre-clinical data and author of pre-clinical chapters in strategic and submission documents (e.g. IB).- Responsible as study co-ordinator to organize human ADME studies in collaboration with the clinical trial leader, isotope laboratory and Technical Resreach & Development.- Dosimetry calculation for human ADME studies and submission to Health Authorities.- Author of clinical laboratory manuals and co-author of clinical protocols and clinical study reports. - Organizing and supervising the outsourcing of studies.- Radiation safety officer according to Swiss law of laboratories and freezer storage rooms (organizing training, radioactive waste disposal, storage and transport).- Leading the analytical part of a clinical iron absorption study. Identifiying a non-radioactive solution by an interdisciplinary collaboration with academic Geo Chemistry and applying the isotope dilution principle using stable Fe-58 to quantify drug-related iron uptake.

Laboratory head (Fellow) of the analytical unit in the local Isotope Laboratory (IL) section of Drug Metabolism and Pharmacokinetics, Development, Novartis Pharma AG in Basel, Switzerland. - Responsible for the analysis, storage, stability monitoring and purification of certified stable and radiolabeled compounds. Release analysis by using analytical techniques such as HPLC-UV and –RA, micro-HPLC-ITMS, LSC, NMR, CE.- Responsible for the writing and filing of reports. Overall project planning (time lines) within the IL in collaboration with the synthesis laboratory heads and communication of the project status to superiors. Contributes to planning and organization of the section.- Involved in the overall planning of human ADME studies.- Representing the IL in several global project teams. - Leading 3 lab associates including training and performance assessment and objectives setting.- Direction of the development of analytical methods and adaptation of existing methods.