George Makris

- Design and implementation of end-to-end, risk-based quality strategies following identification of Critical to Quality factors (CtQs) and the use of data analytics tools - Development of audit strategy plans - Authoring of Quality Narrative - GCP consultation for Potential Serious Breach evaluation of escalated Significant Events - Inspection readiness and preparation support

- Design and Implementation of QA strategies across molecule, defining the activities, partnering and engaging with business stakeholders, using data analytics and insights to target the activities that need to be conducted to provide evidence of effective implementation - Delivery of activities to assess QA status including preparation, conduct, presentation and timely reporting of outcomes of audits and evaluation of actions taken looking for areas of opportunity for process improvement beyond the individual findings - Summarize the quality position and conclusions for molecules using generated quality evidence into the Quality Briefing in order to influence and effect change and positive outcomes - Lead discussions of unresolved issues with Senior Management; manage ‘for cause’, critical, and/or complex quality issues and escalate significant issues to PDQ management

- Oversight of FSP resources, qualifications and their ability to deliver according to the service agreement through monitoring and management of established and negotiated KPIs/metrics - Finance activities and resource planning - Assessing satisfaction, identifying gaps and driving efficiencies and performance improvements

- Planning and executing compliance visits/QC checks to various high-risk sites/studies - Primary point of contact to the local clinical Team in the areas of process, quality and systems-related issues and consulting SME to the global clinical Teams on country-specific issues - Core member of the CAPA management Team consulted for criticality assessment, root cause analysis, impact assessment and action recommendation - Local GCP-related process development, update, improvement and alignment with global SOPs and applicable laws and regulations - New hire and on-the-job training, mentoring and coaching to clinical operations staff including Study Start Up, Project Management and CRA Teams - GCP expert in internal Quality Management Reviews - Enabled successful outcomes by active involvement and management of seven internal GCP Audits and a regulatory Site Inspection - Continuous effective control of clinical trial metrics within established thresholds - SME in EU & Canada for global metrics oversight tool, providing support on system use and effective implementation

- Guidance and support to medical, clinical, regulatory and drug safety Teams on the effective implementation of ICH-GCP, procedural documents, regulations and guidelines - Periodic review, analysis and reporting of KPIs/metrics and implementation of actions to improve Medical Affairs efficiencies - Contributed towards the sustainment of highest quality standard ratings for the Affiliate - Established and facilitated a regional community in a global communication platform connecting peers from EU countries and enabling fast and efficient knowledge sharing and alignment - Delivered lectures and organized and led workshops for clinical staff during three local Clinical Investigator Training Programs

- On-time and in high quality execution of all project stages including site feasibility, contract negotiations and budget set-up, document translations, clinical trial application preparations and submissions, Investigator/hospital/local vendor payments, training of sites and local vendors, risk-based remote and onsite monitoring, DBL and close out - Interaction with regional PM Teams located in EU hub countries and the US - Mentoring and on-the-job training of colleague CRAs during on-site co-monitoring and handover visits in study processes and systems - SME for Safety with ongoing support, coaching and training to CRA and drug safety colleagues - Certified Trainer for the Sponsor eCRF platform, organizing and executing multiple site trainings - Experience in Oncology, Hematology, Neurology and Nephrology in Phases II-IV - Successful management of three Investigator Audits at Sites of responsibility

- Personal interest in the molecular biology and enzymology of Staphylococcus aureus

- Participating in several in-vivo clinical trials for use in dermatology - Strict implementation of SOPs in patient sampling, sample processing and record keeping - QC assessment exercises and training to ensure updates with operating procedures and Sponsor protocols - Involved in the set up and operation of a Mobile Laboratory for the SRC, enabling human skin sampling and processing at various UK sites

- Laboratory assistant for the Infection Control Unit performing routine diagnostic work during the period of the PhD dissertation write-up