Products category : Probiotics, medical devices, drugs• Regulatory responsibilities: file/notification redaction for new food supplements and medical devices (classIIa) – Europe&international, packaging development according to the FS/MD legislation, authorities inspection coordination (AFMPS, NB, AFSCA), Drug variation coordination, Introduction and follow up a dossier to obtain a drug reimbursement by Inami, • Quality responsibilities: Quality system improvement for food supplement, medical devices and drugs (Process clarification, SOPs update, training, …), Sub-contractors relations formalization through Quality agreements implementation, medical devices and food supplement batches release, complaints handling, data analysis and quality management annual report coordination to highlight potential trends.• New product launch support: Ensure the conformity of new products by putting in place a structure allowing efficient coordination of product transfer from development to commercial and commercial to commercial (product transfer documentation), Support the market launch of new product (Quality&Regulatory topics)

- Be the interface between new GIO sites (Rosia Italy/Marburg Germany) and global functions – issues facilitation, integration planning review, …- Coordinate cross functional projects as business application (IT) migration from NVS to GSK hardware, data disposition management to ensure the data protection during and after the integration, transfer of legal contracts to fit with the GSK distribution model, …- Communicate regularly the Integration results and progress to the GIO board

• Products transferred: bacterial/viral vaccines & adjuvant manufacturing• Manufacturing Steps transferred: fermentation/purification/conjugation/adsorption / formulation/filling/packaging activities• Transfer done: - Development (final scale) to Phase III activities (Belgium/Japan)- Phase III to commercial activities (Belgium/Hungary)- Commercial to commercial activities (Singapore/India/China/Belgium)• Activities coordinated during transfer (project management) : Manage and lead product and process transfer projects :- Coordinate the product and process transfer from kick off until the file registration- Build the transfer team and lead transfer meeting (transversal team around 10 people)- Define transfer objectives, milestones, constraints, resources a cost through a project transfer plan.- Manage risks linked to transfer - Facilitate the equipment selection with engineering partners based on GMP and manufacturing process requirements- Coordinate transfer information from donor to receiving site (raw materials, Process manufacturing, QC, QA, logistics activities) - Support redaction and approve the receiving site documentation required for consistency batches (BR, SOP, MOP, ….). - Write comparability protocol and report collecting consistency batches data- Support trial and validation batches manufacturing- Coordinate deviation management linked to the validation batches- Review the technical part of file before registration- Lead an after action review and the transfer close out meeting.

New Passive insulated shipping container development (for shipment), qualification and implementation  Packaging qualification according to ISTA/ASTM standards (vibration, drops, …) -As project coordinator, writing of qualification protocol and reports, tests supervision (realized in a certified laboratory for physical challenge test), analyze results.  Cold chain qualification : Qualification of packaging according to GSK and WHO temperature profiles - Writing of Qualification protocol/reports, probes location determination, supervision of tests (realized with a third party laboratory). Implementation of qualified packaging for routine shipment: Way of working writing, operators training

 Facility supervision – back up (Plan, manage, deal routine blocking points, deal deviation, report) – I had the opportunity to be trained to Fermentation & bulk purification processes - Certification for manipulation under laminar flow (cell culture…)) Techniques standardization between production facilities (through internal audit, operators training, …) Responsible of non-viable environment monitoring in production areas  Process Improvement : raw material performance anlysis through biological suitability tests (lab launch) Total Quality Management – program implementation (autonomous team, TRS equipment, simplification and review of procedure…); Introduction to Industrial Excellence and lean six sigma)