At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to more than 90 000 colleagues worldwide, with 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

The Quality Assurance Department is an independent department of SGS Clinical Research. It is responsible for the Quality Management System. This system covers Quality Documents, training and qualification, resolution and documentation of deviations, auditing activities and dedicated quality support to all departments. The objective is to protect safety and wellbeing of clinical trial subjects and reliability of trial data through adherence to ‘Good Clinical Practice’ and other relevant international quality standards (GxP), applicable regulatory requirements for Clinical Research, and internal procedures.

We are currently looking for a Quality Compliance Manager.

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 carry out the SGS ‘culture of quality’. When process improvement opportunities present themselves in both the operations or QA area, you identify and promote them. You develop training materials and/or deliver training to assure quality awareness all around.

Additional responsibilities:

• 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. Knowledge of other languages is a plus;
• 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.

What we have to offer:

Were you already considering a big switch in your career? Maybe this could be your next step. At SGS you can count on an interesting position where you can take responsibility. Come enjoy our fun team of colleagues and on top of that, we will reward you with an interesting salary package (incl. company car, retirement plan, meal vouchers, …)

Do you want to be part of this?
We are looking forward hearing from you! Send us your story and your resume via our website jobs.sgs.com and maybe you will soon join us for work ànd coffee breaks. Still have questions? Pascal Plessers can give you more details about the job. Send him an e-mail at [email protected]