Clinical Trial Quality Specialist
We are currently seeking a highly skilled Clinical Trial Quality Specialist to join our Medicines Quality Organisation (MQO) team on a permanent basis. This role requires experience working with clinical trials and quality management systems. The ideal candidate will be a Senior Associate/Principal Associate level professional who can contribute to the development of area-specific procedures and required tools, resource documents, and supplemental materials.
* Develop and review quality system documents, ensuring regional and/or affiliate quality system requirements have clear accountabilities.
* Recommend new quality system documents or changes to existing quality system documents where applicable.
* Advise on appropriate 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, ensuring events are appropriately documented, escalated, and completed.
* Consult on root cause analysis and corrective/preventive actions (CAPA), including review/approval as necessary.
* Provides input into risk assessments, audit planning, and/or quality plans based on identified signal/risks/gaps.
* Complete self-inspections and drive improvements that are meaningful and actionable.
* Ensure local implementation of the quality systems as necessary.
* Support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
Requirements
* Bachelor's Degree in a science/technology/health care-related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated work environment.
* Experience in a quality control/quality assurance role.
* Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
* Demonstrated ability to prioritize and handle multiple concurrent tasks.
* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.
* Effective organisation/self-management skills.
* Ability to work independently and as part of a team.