Our client, a global pharmaceutical organization, is seeking an experienced Clinical Trial Quality Representative to join their Medicines Quality Organisation (MQO) team on a permanent basis.
About the Role
This is a senior associate/principal associate-level position that offers hybrid working. The successful candidate will have experience working with clinical trials and quality management systems.
Main Responsibilities
* Contribute to the development of area-specific procedures and required tools, resource documents, and supplemental materials.
* Review and approve quality system documents, ensuring regional and/or affiliate quality system requirements are clear and accountabilities are defined.
* Recommend new quality system documents or changes to existing ones where applicable.
* Advise on training for implementation and documentation.
* Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
* Responsible for deviations, change controls, notification to management, and root cause analysis and corrective/preventive actions.
Requirements
* Bachelor's degree in a science/technology/healthcare-related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated work environment.
* Experience in quality control/quality assurance and functional business areas such as medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Strong interpersonal skills and ability to work independently and as part of a team.