Héron, Walloon Region, Belgium
PERSONAL PROFILE Industrial pharmacist by training, I am an experienced leader in the GMP pharmaceutical environment with significant accomplishments in Pharmaceutical Development and Manufacturing. Looking for a leadership position to share my experience, collaborate with various stakeholders, lead and coach teams to reach objectives. I am both a team player and a dynamic leader, passionate and enthusiast. What I can offer with my swiss knife profile? SKILLS Team management and coaching • Animate a team and make the work pleasant, build trust truly • Take responsibility for my team, be a leader, coach and advisor • Remove rocks on the road, solution oriented • Work as a team player, communicate openly and sustainably achieve team objectives • Assess and develop the team with an appropriate training plan and be accountable for the team efficiency • Collaborate with a collective and emotional intelligence • Manage OPEX and CAPEX budget of the department Quality and HSE • Perform the QA review of deviation notification and lead investigation • Perform pharmaceutical drug product/finished good release as QP • Implement and manage QMS with regards to HSE, Quality, Cost and Delivery, including Industry 4.0 concept (Deviation, Investigation, CAPA plan) • Provide expertise related to business processes from raw material to drug product (Eudralex, ISO - ICH Q8, ICH Q9, ICH Q10) • Familiar with internal and regulatory audits related to GMP purpose • Collaborate transversally to ensure all quality requirements are in place • Continuous improvement of business processes Project Management / PMO • Lead project and portfolio from ideation to closure with an effective tracking of gates deliverables, timelines, budget and health (KPI's) • Plan and execute project, manage people and capacity, forecast resource • Coordinate project teams and stakeholders through steerco meetings and governance body • Collaborate with finance, purchasing, suppliers and external stakeholders (Universities, equipment suppliers, consultancy agencies, institutional organisation eg. Walloon Region) • Lead monthly project review with the management accordingly to governance • Generate new ideas and proposals for global implementation, identify process gaps/areas for process improvement, develop and implement solutions for operational methodology and optimization of processes • Hold the change management and support PM community to reach the objectives with support from the management
Manage, lead and reorganise the QA operational and External Affairs teams for further organisational dimension. Shape and lean Quality processes.
Lead a team of QPL's and act as a Quality Product Lead, exchanging with customers about Quality, QC and Regulatory matters (Europe, US and Japan) for IND. Act as Qualified Person, interact transversaly with internal stakeholders (USP/ DSP/ F&F) to assess productions risks , deviations and OOS. Interact closely with QA Operational for batch review and release of clinical batches.
- Implementation of a PMO Transversal Governance through the Pharmaceutical Development Department - Improve the management of projects, training and coaching of project managers and follow-up of capacity management and budget (eg. gate/milestones, resources, budget & risks) to ensure an effective prioritization and decision-making within departments - Responsible person for Change Management through the teams and implementation of new processes and use of PM tool (Planisware)
- Develop strategy of investment and resource allocation to reinternalize projects developed externally - Grow and engage manufacturing team to deliver faster and safer CTM - Lead the strategic transformation of the conventional processes into the Industry 4.0 concept
Accountable for GxP Compliance, Equipment and Premises. I am currently the accountable person for the complete revamping of the pilot plant and the implementation of a fir-for-purpose ERP to drive our business processes through a lean and agile IT solution and efficient SOPs. Taking care of my team, we grow all together...
- Operational management of the pilot plant & warehouse in accordance with GMP compliance, in order to pass successfully audits and deliver GMP Clinical trials. - Responsible person for the implementation of Process Analytical Technology (PAT) on equipment and QbD in formulation/process development (e.g. NIR, FBRM, Raman and DoE) - Set up and control of department budget (DOA) - Set up of business cases for continuous improvement or for life cycle management of mature products - Set up of a technology platform in collaboration with universities and pharma companies - Continuous Business improvement within the department : simplification of SOPs regulating the pilot plant in order to establish efficient workflows - Accountable for purchasing, set up and qualification of new equipment for pharmaceutical development - Project management for the refurbishment of the pilot plant - Project leader for DP formulation optimization - HSE responsible person for the pilot plant
- DP project leader : set up of the new manufacturing line of equipment (dry granulation), coordination between different services to set-up, qualify equipment and launch the first clinical trials. - Optimization of Zyrtec-D process : improvement of the formulation - Atarax project leader : to drive and lead the change control regarding the new drying process of hydroxyzine and control impact on DP.