QUALITY ASSURANCE MANAGER

More than a job. We make the Difference.  

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To strengthen our Quality Unit, our fast growing company is currently seeking a highly motivated and enthusiastic

QUALITY ASSURANCE MANAGER

This position is based in Mont-Saint-Guibert (Belgium)

Purpose

• Oversee and develop the Quality Management System for Belgium
• Drive  and support the harmonization of the CSM European/Global Quality system together with adoption of Clinigen QMS systems.
• Oversee the Quality Assurance team and work with other functions on site to drive GMP compliance and improvement
• Personally to manage client audit program, planning, hosting and follow-up

Main responsibilities

• Ensure the availability, the update and continuous improvement of the CSM EU quality management system.
• Communicate operational issues and opportunities for improvement to department leaders.
• Function as Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits.
• Contribute to the quality department's activities to ensure continuity of operations.
•  Know, understand and comply with the company’s standard operation procedures and policies.
• Perform other related job duties in the context of Quality Assurance as assigned by EU Director.
• Perform and contribute to qualification of suppliers and vendors of CSM EU.
• Contribute to the preparation, hosting and follow-up regulatory inspections at CSM Belgium

Education and Experience

• Pharmacist´s degree or equivalent degree in science study, e.g. Veterinary or Biology
• Experience in Quality Assurance (5 years)
• Experience in leading Quality audits/inspections-internal and external. Ideally as qualified auditor.
• Experiences with clinical trials and IMP. Experienced in GMP, GDP, and GCP requirements
• Experience in working in a matrix organization

Skills

• Excellent communication and intercultural skills
• People management skills
• Team worker and team spirit
• Customer oriented
• High organizational and planning skills
• Work with accuracy and reliability
• Good dose of assertiveness
• Good computer skills: MS office, other office software
• Fluent in French and English (any additional language is an asset)

Offer

At CSM, we understand our work within the clinical trial process could not happen without our dedicated employees. That’s why we are striving to provide our employees with a challenging working environment which still promotes a work-life balance. We provide competitive compensation and a complete benefits package.

If you have the desire to play your part in making a difference in the lives of patients participating in clinical trials, we want you to apply today by submitting your resume to: HREurope@csmondemand.com

CSM, a Clinigen company, is providing innovative clinical trial supplies and biological sample management services since 1997. With two facilities in Post-Brexit EU and three in the US, CSM is committed to ensuring clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.