Technical :*Creation and development of the new Repack Department to become the EU center of excellence.Elaboration of +/- 60 operational documentation.Definition of the Quality strategy.Setting-up of the ‘GMP’ and Materials Preparation areas : installation and validation of equipments (Printing of labels and boxes; folding of leaflets; cameras, ....)*Continuous improvement.Implementation of the serialization : extension of the Repack facility (preparation rooms and… Show more Technical :*Creation and development of the new Repack Department to become the EU center of excellence.Elaboration of +/- 60 operational documentation.Definition of the Quality strategy.Setting-up of the ‘GMP’ and Materials Preparation areas : installation and validation of equipments (Printing of labels and boxes; folding of leaflets; cameras, ....)*Continuous improvement.Implementation of the serialization : extension of the Repack facility (preparation rooms and storage locations); installation and validation of new serialized equipments (Manual station; Print & Label machine,…).Processes improvement : revision of flows and quality checks (Leadtime reduction of 10%; increase of volume : 40% in 2020 and 50% till August 2021)People Management :*Coaching and developing the Repack team (service provider) to reach and maintain the appropriate ‘GMP’ quality mindset*Operational efficiency management (Due date on time 3% over target)*Head count assessment*Support the team in the day-to-day operations (lead by example) Quality :*Represent the repack department during the Health Authorities Inspections,… .Direct interaction with auditors and no Major remark*Strong relationship with QA .Issues analysis with the operational team and propose pragmatic solutions to QASite management :*Manage the service providers (Logistic operations/Security/Facilities/Quality/Transportation) in dotted line *Manage the J&J Operation Team – 5 exempts in direct line*Responsible of the Distribution Center (+/- 150 persons) *Overall overview on the full logistic flow (inbound/storage/repack/outbound/destruction) Show less

Technical : *Implementation of a new ‘Clinical studies’ warehouse and packaging areas (+/- 1200m²)*Design the flows and facilities (cells, storage areas, offices,…) *Layout concept definition and follow-up with engineers and architects*Follow up the equipments installation *Update the operational procedures and documentsPeople Management :*Supervision of +/- 30 persons *Hiring and evaluation of blue and white collars*Interaction with Human resources and… Show more Technical : *Implementation of a new ‘Clinical studies’ warehouse and packaging areas (+/- 1200m²)*Design the flows and facilities (cells, storage areas, offices,…) *Layout concept definition and follow-up with engineers and architects*Follow up the equipments installation *Update the operational procedures and documentsPeople Management :*Supervision of +/- 30 persons *Hiring and evaluation of blue and white collars*Interaction with Human resources and social partners*Motivate the teams to achieve maximum productivity while guaranteeing qualityQuality :*Represent the warehouse and packaging departments during the Health Authorities Inspections,….Direct interaction with auditors and no Major remark*Quality compliance responsible for the warehouse and packaging/labelling operations (Deviations, corrective actions, KPIs, ….)*Training plans managementPlanning : *Plan activities and allocate resources according to the workload *Orders preparation management*Negotiation of due dates, split of orders, …Safety : *Safety rules Improvement in the Warehouse (appropriate gowning 2-8°C; security shoes; visitors rules; Master Safety Data Sheets; Dangerous Goods cabinet, ….)*Implementation of weekly Gemba walk and action plan definition; 5S implementation Show less

*Translating study protocols into operational demands and operational feasibility confirmation *Define the operational set-up (label definition, labelling/packaging/distribution)*Packaging ‘Make or Buy’ decision based on cost and feasibility*Follow-up the labelling/packaging with the internal packaging site*External vendors performance management

Operational : *Planning management (project and team)*Packaging and Labelling specification definitionPeople management : *Management of 3 teams +/- 20 persons (Packaging/Labelling, Quality Control, Warehouse/ distribution)*Hiring and evaluating the team Quality :*Prepare internal and external audits *Batch records review*Deviations, corrective actions implementation