Within E&PS (Engineering & Property Services) various activities are centrally managed and controlled. These activities can be compliance critical such as calibration, certification, qualification, mapping, cleaning, pest control, change management, deviation management, document management, data integrity, CMMS system, etc. As central compliance engineer, my responsibility is to manage and share these processes/methodologies with local compliance functions of operational groups. Structuring initiatives and gatekeeping of these processes within E&PS (Belgium Campus). I act as E&PS' general point of contact for compliance, support various inspections, support global J&J optimization initiatives and maintain good relationships with business partners, as well as managing managed service teams.

After the six months assignment as QA Qualification manager I was offered the opportunity to continue to fulfill this role for the long term. In this position I am responsible for a team of QA qualification engineers in order to ensure compliance of all qualification activities related to lab equipment, production equipment and facilities / utilities within SMPD (Small Molecule Pharmaceutical Development) and JSC (Janssen Supply Chain) organization.

During this temporarily assignment as QA qualification manager I am responsible for a team of QA qualification engineers in order to ensure compliance of all qualification activities related to lab equipment, production equipment and facilities / utilities within SMPD (Small Molecule Pharmaceutical Development) and JSC (Janssen Supply Chain) organization. This temporary assignment is a development opportunity to grow and develop my servant leadership skills.

Temporarily exempted as senior QA Qualification engineer facility/utility and labo equipment to contribute two major projects at the J&J Beerse site:* The LION (Labs In One Network) project is launched within the SMPD (Small Molecule Pharmaceutical Development) organisation to relocated labs together in one new building. The LION building will host 250 scientists and there capabilities and consists of flexible & modular lab units developed for the future. The building consists of 4.472 m² labs, 4.389 m² writing area, offices and common area and 1.542 m² utility area for GMP and non-GMP critical utilities (HVAC, water, gasses, monitoring) divided over a basement, 3 floors and a technical penthouse. About 1600 GMP and development equipments will gradually be moved in with strong focus on business continuity. In my role I’m QA responsible for the entire building qualification (GMP facility/utility) and relocation qualification of all GMP climatic and analytical equipment.* Within the Janssen Supply Chain (JSC) organisation the China compliance project is initiated to comply with recently changed Chinese regulations. Major changes will be implemented within the existing formulation, filling and packaging building. Architectural changes and installation of new HVAC units will lead to segregated areas and adjusted classifications within the entire building. The project will have significant impact on facility/utility qualification and material & personnel flows. As QA Qualification it is my responsibility to ensure the building and all its facility/utility maintain in their qualified state in front, during and after the project.

Quality assurance for facilities/utilities qualification in support of commercial and clinical manufacturing and testing. Facilities and utilities, such as pharmaceutical water and steam systems, cold rooms, HVAC, EMS and PLC/SCADA in a GMP regulated environment.My activities include review and approval of change control, events / OOS, CAPA, URS, impact analysis, IQ/OQ/PQ in order to maintain compliance to regulations, guidelines, J&J policies and standards. Next to these activities I'm also responsible to review and improve the approach for clean area classification according to Eudralex annex 1 and ISO 14644, and to improve the strategy for temperature mapping of cold/ambient storage areas.

Directing a team of > 200 young and enthusiastic people with the responsibility to maintain and improve the educational policy of the group.My approach of directing scouting is based on collaboration and delegation. It is my commitment to guide the group, mediate conflicts and organize activities to support young people in their physical and mental development, that they may play constructive roles in society.