Clinical Trial Quality Representative
We are recruiting for a Clinical Trial Quality Representative to join our Medicines Quality Organisation (MQO) team on a permanent basis.
About the Role
This Senior Associate/Principal Associate level role offers hybrid working and requires experience working with Clinical Trials and Quality Management Systems.
A more detailed role profile is available upon request.
Responsibilities
* Contribute to the development of area-specific procedures, resource documents, and supplemental materials.
* Evaluate and approve quality system documents as assigned.
* Ensure regional and affiliate quality system requirements have clear accountabilities.
* Recommend new or changed quality system documents where applicable.
* Provide training and consultation on interpretation and practical application of external requirements, standards, and procedures.
* Manage deviations, change controls, notifications, and self-inspections.
* Drive improvements and provide input into risk assessments, audit planning, and quality plans.
Requirements
* Bachelor's Degree in a science, technology, or healthcare-related field or equivalent work experience.
* Experience applying quality systems in a regulated environment.
* Background in quality control or assurance and functional business areas like medical writing, regulatory affairs, or clinical trial management.
* Effective project management, communication, and interpersonal skills.
* Ability to prioritize tasks, work independently, and as part of a team.
About Us
We are a global pharma organisation committed to excellence in medicines quality.