Clinical Trial Quality Representative
Our client is a global pharmaceutical organization seeking a Clinical Trial Quality Representative to join their Medicines Quality Organization (MQO) team on a permanent basis. The ideal candidate will have experience working with clinical trials and quality management systems.
Responsibilities
* We are looking for someone to contribute to the development of area-specific procedures and required tools, including reviewing and approving quality system documents as assigned.
* The successful candidate will recommend new quality system documents or changes to existing ones where applicable.
* This role requires advising on appropriate training for implementation and documentation.
* You will provide consultation on interpreting and applying external requirements, standards, and procedures.
* The representative will be responsible for managing deviations, change controls, and Notification to Management (NTM), ensuring events are properly documented and escalated.
* They will consult on root cause analysis and corrective/preventive actions (CAPA), including review and approval as necessary.
* The successful candidate will provide input into risk assessments, audit planning, and quality plans based on identified signals, risks, and gaps.
* They will conduct self-inspections and drive meaningful improvements.
* The representative will ensure local implementation of quality systems as needed.
* Additionally, they will provide support related to external party management, such as third-party organizations and business alliance partners.
Requirements
* A Bachelor's Degree in a science, technology, or healthcare-related field or equivalent work experience.
* The ability to apply quality systems within a regulated work environment.
* Experience in a quality control/quality assurance role.
* Experience in defined functional business areas, such as medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* The ability to communicate effectively, both written and verbal, and influence others.
* The ability to prioritize and handle multiple concurrent tasks.
* Strong interpersonal skills with flexibility in varying environments/geographies.
* Effective organization/self-management skills.
* The ability to work independently and as part of a team.