Positive, energetic and dedicated to contribute to my life-time vision: "Elderly are the future".
Strong in operational back-office function to support the biggest asset of a company: the people.
R&D Quality Expert
Since September 2015
Drive continuous improvement of the medical Research & Development processes together with the Process Owner to ensure innovative, safe and effective products can be made available to patients with a short time to market. Provide quality support to the Clinical Unit Research & Development team. Assist with writing, reviewing and approving standard operating procedures/work instructions and forms to ensure regulatory compliance. Design review: Participate in and guide regular multi-discipline review of the design in development Design History File review: Confirm the design documentation is compliant with applicable regulations Design Risk management: Participate in and guide design risk analysis CAPA process owner of R&D related CAPAs to ensure appropriate corrective actions are implemented to correct design issues and improve the development process Provide statistical trend analysis for KPIs on the quality management system. Monitor the R&D related processes to identify potential deficiencies, discuss these issues with the respective process owner and initiate additional actions like CAPAs. This includes providing input for the quarterly Clinical Unit Quality Management Review. Perform internal audits. Provide market surveillance on current regulatory, quality and product environments. Ensure the R&D team is trained in quality management system needs and expectations.
Senior Manager function Quality and Risk Management for Clinical Development and Clinical Operations
August 2014 --- August 2015
Management of GCP-Inspections performed by Regulatory Inspectorates (RI) such as European Medicines Agency, Belgium: AFMPS, United Kingdom: MHRA, Germany: PEI - Pre-inspection activities: coordination of Inspection Dossier as per RI- guidelines (timely delivery), preparation of Inspected business-experts and study teams, close constructive collaboration with regional QRM, local Quality Assurance representative, Clinical Development Quality Assurance (audit team), QA R&D (GCLP) and QA NPI (GMP) - During the inspection: full lead-coordination, on-site support and remote support - Inspection follow-up (Corrective Action, Preventative Action Follow-Up “CAPA-management”), support root-cause analyses – link overarching topics with the appropriate stakeholder lessons learned in the methodology of inspection management Lead-coordination for timely delivery of “Corrective Action Preventative Action – Report” and “request for clarification” to RI – with endorsement of Senior Management. - Reporting and escalation to internal Governing functions (status + identified potential bottle necks) - Coordinating inspection readiness-support (with regional QRM, audit team, Trial Master File -team) to Phase III Clinical study team in the event of an inspection after the regulatory file submission People management: leading multi-functional teams towards common goals (Conflict management, influencing and driving change). Coaching people in their function on how they can deliver quality on a day by day basis. e.g. by one-on-one feedback-sessions, setting clear objectives and timings, acknowledging people's expertise, resource management calculations) Provide Client Focused “tailored” recommendations for Consultancy questions in the ICH - Good Clinical Practice context Roll-out of enhanced Risk Management Framework: retrieving buy-in of stakeholders and providing hands-on support during its implementation.
Manager Quality and Risk Management - central Human Research
May 2013 --- July 2014
*Transformation: Member of QRM Platform: “Oversight” (2013-2014): - Definition of Oversight, active participation to development of key-principles that contribute to change of mindset on Oversight Management and Level 1 QC activities throughout the business, these key-principles are being captured in the development of the Handbook, sharing of key areas for successful implementation (as: train the trainer, buy-in of client – know your clients, follow-up of implementation) - Active participation to development of Handbook on Third Party Oversight. -Transformation: Consulted for Clinical Operations operating model review workshop (April 2012) -Support business and QRM Senior Management in implementation process of Trial Master File (TMF) throughout GSK Vaccines as part of MHRA inspection follow-up (from August 2013 onwards): onboarding of stakeholders who contribute to the TMF, review of associated SOPs and guidance, follow-up of CAPA-deliverables and timings. Ensuring correct information is available in time to influence all non-Clinical Operations groups for contributing to the TMF as according to GCP. *Provide Client Focused “tailored” recommendations for Consultancy questions in the ICH - Good Clinical Practice context (+ content of Sr. Mgr of current function)
Global Clinical Project Manager (GCPM, GTM)
November 2007 --- May 2013
* Project manager of Clinical studies (Multi-country HPV studies, Phase III-Malaria study, supported studies in collaboration with researchers): * key point of contact in matrix structure (central and regional functions) * coordinate the Clinical Operational Aspects of a clinical study from start to end, in compliance with ICH-GCP guidelines and GSK policies/SOPs * collaboration with Third Parties * act as escalation point for operational stakeholders * assessment of training needs and providing adjusted updated training to different functions * use of project management tools (MS project, RACI, communication plan), study risk and feasibility assessment * Consulted and involved in contract – and budget negotiations
Consultant (working for GSK Biologicals)
January 2007 --- January 2009
Clinical Study Nurse (SN)
January 2006 --- January 2007
Clinical Study Nurse (SN)
January 2004 --- January 2006
ProactivityAuthenticityCollaborationCommunicativeCoordinationCritical thinkingIndependenceOrganizationProblem solvingStrategic thinkingTrust
Master in Nursing: Option Geriatric Care from University of Leuven in 2006
Bachelor in Geriatric Nursing from in 2003