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.
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.
You are fluently writing and speaking English, you have knowledge of Dutch.
You possess excellent communication and problem solving 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.