Clinical Trial Quality Assurance Professional
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* Contribute to the development of area-specific quality procedures, tools, and resource documents. Ensure regional and/or affiliate quality system requirements have clear accountabilities.
* Recommend new quality system documents or changes to existing ones where applicable.
* Advise on training implementation and documentation.
* Provide consultation on interpreting and applying external requirements, standards, and procedures.
* Responsible for managing deviations, change controls, and ensuring events are 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 quality plans based on identified signals/risks/gaps.
* Complete self-inspections and drive meaningful improvements.
* Ensure local implementation of quality systems as necessary.
* Support external party management as assigned.
Requirements
* Bachelor's Degree in a science, technology, or healthcare-related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated work environment.
* Experience in quality control/quality assurance roles.
* Functional business areas such as medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Ability to communicate effectively and influence others.
* Prioritize multiple concurrent tasks efficiently.
* Strong interpersonal skills with flexibility in various environments/geographies.
* Effective organization/self-management skills.
* Ability to work independently and collaboratively as part of a team.