Neuchâtel, Neuchâtel, Switzerland
I am a quality driven, goal oriented clinical research professional with a background in academia, the CRO and pharmaceutical industries and a passion for creating trusted and meaningful relationships with my Teammates, sharing my learnings and enabling them to reach their goals faster and with better quality.
- 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