JOB DESCRIPTION :
The Clinical division of Abbott Medical Devices in Belgium is looking for a Clinical Trial Quality Assurance Specialist.
The purpose of the job is to work with Clinical Affairs organization process owners to develop, update and maintain the Quality System Processes, Procedures, and tools to ensure compliance with applicable US and International standards and regulations.
More Specifically, the Clinical Trial Quality Assurance Specialist will :
Provide clinical investigation quality oversight and execute Quality Assurance tasks for clinical investigations under approved processes
Audit institutions, contract research organizations, and Abbott Clinical operations associated with clinical investigations to identify regulatory compliance risks.
Support external audits and inspections as required.
Provide maintenance support of the quality assurance tasks
Provide Clinical process and procedure development support
Provide project management support, as required
Provide GCP coaching and training support
Maintain relationships and communications with business and other functional areas
Support all One quality systems initiatives as identified by management
Your Profile :
Master’s degree in Business, Scientific or related field
Minimum 4 years of Clinical or Quality functional experience.
Excellent communication and customer service skills and strong team motivation skills in order to manage work that requires effective delivery to internal customers.
Fast learner, flexible and ability to work independently when necessary
Fluency in English (any additional language is an asset)
Flexibility to travel (50% travel)