Senior Quality & Compliance consultant

CTG has officially been part of Cegeka, a leading international IT service provider, since the end of 2023. This collaboration strengthens our expertise and innovation power, further increasing our impact in North America and Europe. Together we deliver innovative digital transformation solutions for various sectors worldwide.   We are looking for experienced Quality & Compliance Consultants to join our team on various projects in the Life Sciences sector. In this sector, strict guidelines and good practices (GxP) play a crucial role to ensure patient safety and product quality. You ensure that these regulations are correctly applied to critical systems and processes. Our consultants work on compliance projects within IT, but also support other departments or perform operational roles. What makes our team unique is the combination of scientific expertise and interest or experience in IT within the Life Sciences sector. 

• As a Quality & Compliance Consultant, you play a key role in the success of our projects. You are responsible for the planning, coordination, implementation and reporting of projects around Computer System Validation (CSV), QA/QC and IT compliance. You deliver high quality documentation according to applicable guidelines and regulations. 
• You perform assessments, gap and risk analyses and effortlessly translate your findings into concrete improvement plans. 
• You drive (process) improvements in the areas of CSV, quality and compliance, always taking a risk-based approach and increasing efficiency. 
• In addition, you design compliance strategies, frameworks and methodologies, and provide clients with valuable advice and guidance. 
• Thanks to your experience, you will inspire and coach junior colleagues to reach their full potential, and contribute to the growth of our team. 

• Strong scientific base: You have a degree in a scientific field, such as (bio)chemistry, biomedical sciences, or bioengineering, or you offer relevant experience.
• Compliance experience: We would like a minimum of 3 years of compliance experience within the Life Sciences sector.
• Thorough regulatory knowledge: You are versed in laws and regulations such as GxP, 21 CFR Part 11 and GAMP5. Additional knowledge of ISO standards (9001, 27001) is a nice touch. 
• Focus on quality and reliability: You combine a strong work ethic with flexibility and accuracy. You keep appointments punctually and always put quality first. 
• Project management skills: You have experience managing projects and know how to effectively achieve goals within set deadlines. 
• Strategic and solution-oriented: With your analytical skills and strategic mindset, you know how to translate complex client needs into practical solutions and action items. 
• Strong communicator and team player: You enjoy working together, but also function well independently. With your communication skills you communicate your ideas clearly, both in English and in Dutch, and ideally also in French.