As the Quality Compliance Manager you ensure the effectiveness of the organization’s Quality Management System for an assigned area of operations. You will report to the Director Quality.
• You try to always meet the agreed timelines and quality objectives. Therefore, you collaborate closely with the assigned areas of operation;
• In order to ensure the development and maintenance of effective quality documents, you collaborate with the assigned areas of operation and you liaise with other areas/departments for cross functional topics to be addressed and created accordingly;
• You are the ‘single point of contact’ for auditors and regulatory inspectors. This means you facilitate and follow up on client audits and regulatory inspections, always in close collaboration with the QA assistant. You also provide leadership and training to operations colleagues in case of these audits and inspections;
• You’re the ‘light in the dark’, you guide the responsible persons in performing adequate Root Cause Analysis. You help them with defining and implementing adequate and compliant Corrective Action and Preventive Action (CAPA) Plans for reported deviations;
• You will analyse and discuss trends in reported deviations and their impact. When needed you will report to the senior management;
• You interpret new or updated regulations and guidelines, policies and procedures as necessary and provide interpretation and consultation to your colleagues regarding these topics.
• You will take responsibility for the QA department’s quality documents and resolution of deviations;
• You will manage a team of QA assistants and QMS Administrator.
• You have obtained a University Degree in sciences, a (para)medical area or pharmaceutical sciences. An equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis;
• You have a ‘track-record’ of at least 8 years’ experience in a university research department, laboratory, or pharmaceutical, biotech, medical devices or similar company. Or a CRO or equivalent combination of education, training and experience;
• You have strong project management and people management skills in a matrix environment.
• Your knowledge of English is as close to ‘mother tongue’ as possible, this in written as well as spoken.
• You possess excellent communications skills;
• You can handle several complex projects or initiatives simultaneously;
• What’s a team without a team player? You love to work in team and can handle stress like a pro, thanks to your well-organised competences;
• You are a responsible and integer person with a real quality mindset and a big interest for customers; your sense of diplomacy and confidentiality is very high;
• You have a strong affinity with (inter)national guidelines and regulations related to clinical research and ability to make decisions based on appropriate interpretations;
• If you have already some experience with an electronic document management system, then this is a big plus, since one of your responsibilities will also include the management oversight of the electronic document management system and the reviewing of the work of the QMS administrator.
Aline Vandermeeren +32 16 30 95 09