Key tasks include :
• Interview and gather background information from Janssen and draft process documents related to Quality Management Systems; assist Janssen in managing approval process
• Lead or participate in the development of departmental processes and tools to improve own and departmental work
• Draft process maps and Standard Operating Procedures (SOPs) for processes. (~ARIS BPM knowledge) – apply LEAN methods
• Develop Responsible, Accountable, Consult, Inform (RACI) diagrams for processes
• Collaborate with other Process and Documentation leads to plan and priorities projects.
2)Maintain relevant planning tools
• Conduct Workshop for non-priority process review
• He/She will oversee procedural document development, training development in collaboration with the responsible BRQC functions to ensure content and requirements of the design are fully transferred and implemented.
• Develop training materials for processes
4)Project Management Skillset
• Conduct PMO activities including weekly status meetings, plans for long-term maintenance of the project management “hypercare” tools and strategies and Frequently Asked Question (FAQ) documents
• PMO support deliverables for developing and tracking transition documents for roles
For the position of QMS Specialist we are looking for candidates with the following profile:
• BSc or BA in a relevant field and at least 6 years of experience in a medium to large scale matrix organization; including quality and compliance related experience in a Pharma R&D, QA or QC
• Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
• Ability to interpret data to develop action plans to improve business, to translate data into information and strategies into executable action plans
• Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills;
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Experience of quality related business processes and practices; experience of the overall drug development process is an asset
More information + how to apply: For more information, please contact Cindy van Gorp on 040 - 7999 010 or – Klik op de solliciteer-button om te solliciteren –
For your application, please use the APPLICATION BUTTON on this page.