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 almost 100 000 colleagues worldwide, with more than 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.
SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities.
SGS Life Sciences has also expertise in the quality control of pharmaceuticals.
In the spirit of growth we are currently looking for a Quality Compliance Manager with an additional role as Quality System Coordinator for the QA department - Mechelen
The Quality Assurance Department is an independent department of SGS Clinical Research. It is responsible for the Quality Management System, which covers all quality documents, training and qualification, resolution and documentation of deviations, auditing activities and dedicated quality support to all departments.
As Quality Compliance Manager, you ensure the robustness and effectiveness of the organization’s Quality Management System (QMS) by ensuring that all activities within the assigned functional areas are performed in compliance with Good Clinical Practice (and other relevant international GxP quality standards), internal Standard Operating Procedures and the applicable regulatory requirements for Clinical Research. You will report to the Quality Assurance Manager.
· You obtain information on new / updated regulations and guidelines, and ensure implementation in the QMS where applicable, in collaboration with the representatives from the assigned functional areas.
· You act as subject matter expert concerning GCP and applicable guidelines and regulations.
· You collaborate with the assigned functional areas to ensure the development and maintenance of effective operational quality documents. If applicable, you will liaise with other areas/departments in order to ensure that cross-functional topics are addressed.
· You are the ‘single point of contact’ for auditors and regulatory inspectors. This means that you facilitate, host and follow up on client audits and regulatory inspections, always in close collaboration with the QA assistant. You also provide leadership and training to operational colleagues in light of these audits and inspections.
· You guide the assigned functional areas in performing adequate Root Cause Analysis and defining and implementing adequate and compliant Corrective Action and Preventive Action (CAPA) Plans for reported deviations.
· 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. You will participate in or lead intra- or interdepartmental process development or improvement projects, as assigned.
As Quality System Coordinator for the QA department, you will coordinate / assist in the writing, implementation, and maintenance (revisions, periodic review) of the quality documents for the QA department. The focus will be on the quality documents related to the information security management system (ISMS) and business continuity (BC). In addition, you will assist in the coordination and follow up on quality issues related to the ISMS and BC.
· 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 6 years of 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 organizational skills;
· Fluent in written and spoken English;
· You possess excellent communication and problem solving skills;
· You have very good writing skills;
· You are assertive and motivated, with a constructive and quality-minded attitude;
· You can handle several complex projects or initiatives simultaneously;
· You have a customer oriented attitude with a high sense of responsibility, integrity, diplomacy and confidentiality;
· You are stress resistant and flexible;
· You have a strong affinity with (inter)national guidelines and regulations related to clinical research and ability to make decisions based on appropriate interpretations.
What we have to offer:
Were you already considering a switch or new step in your career?
Maybe this could be the one!
At SGS you can count on an interesting position where you can take responsibility.
Come enjoy our fun team of colleagues and take your chance to be part of a great and dedicated team!
Do you want to be part of this?
We are looking forward to hearing from you!
Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks.
Still have questions?
Heidi Aerts can give you more details about the job.
Send her an e-mail at [email protected]