Clinical Trial Quality Lead
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Our client is seeking a seasoned professional to fill the role of Clinical Trial Quality Lead. This senior-level position will be responsible for contributing to the development of area-specific procedures and required tools, resource documents, and supplemental materials.
Key responsibilities include reviewing and approving quality system documents, ensuring regional and affiliate quality system requirements have clear accountabilities, recommending new quality system documents or changes to existing ones, advising on appropriate training, providing consultation on interpretation and practical application of external requirements, and consulting on root cause analysis and corrective/preventive actions.
The ideal candidate will have a 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, and effective project and time management skills.
Responsibilities:
* Contribute to the development of area-specific procedures and required tools, resource documents, and supplemental materials.
* Review and approve quality system documents.
* Ensure regional and affiliate quality system requirements have clear accountabilities.
* Recommend new quality system documents or changes to existing ones.
* Advise on appropriate training.
* Provide consultation on interpretation and practical application of external requirements.
* Consult on root cause analysis and corrective/preventive actions.
* Complete self-inspections and drive improvements that are meaningful and actionable.
* Ensure local implementation of the quality systems as necessary.
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.
* Effective project and time management skills.
* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.
* Ability to work independently and as part of a team.