Clinical Trial Quality Specialist
We are seeking an experienced Clinical Trial Quality Specialist to join our team on a permanent basis. The ideal candidate will have a proven track record of working with Clinical Trials and Quality Management Systems, with a strong focus on process improvement and compliance.
Key Responsibilities:
* Contribute to the development of area-specific procedures and tools, ensuring clear accountabilities and effective implementation;
* Recommend new quality system documents or changes to existing ones where applicable;
* Provide consultation on training for implementation and documentation;
* Advise on interpretation and practical application of external requirements, standards, and procedures;
* Responsible for deviations, change controls, and 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 quality plans based on identified signals/risks/gaps;
* Complete self-inspections and drive improvements that are meaningful and actionable;
* Ensure local implementation of 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;
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others;
* Ability to prioritize and handle multiple concurrent tasks;
* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies;
About Us:
We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.