GCP Auditor

This is a fully remote position, open to applicants in Spain.

📋 Description

• Assist in the audit program and clinical initiatives to guarantee adherence to relevant regulations and Precision protocols.

• Offer oversight and specialized knowledge to quality and compliance efforts.

• Aid project teams throughout all phases of a clinical trial.

• Contribute to the Quality Management System encompassing SOPs, training, and CAPA.

• Process and manage documentation for controlled documents as necessary.

• Design and implement training for employees and/or consultants.

• Facilitate client/sponsor audits and assist during regulatory inspections.

• Coordinate and execute assessments of potential and contracted vendors, including conducting vendor audits when necessary.

• Organize and perform internal audits of quality systems.

• Coordinate and carry out investigator site audits.

• Oversee and conduct trial master file audits.

• Engage in computer systems validation projects and the systems change control process.

• Provide QA consultation and support to assigned project teams both internally and externally.

• Manage and address reported quality issues along with any related corrective and preventive actions.

• Monitor quality systems to offer feedback on compliance risks to QA management and highlight areas for improvement.

• Maintain Q&C trackers, databases, metrics, and documentation.

• Adhere to applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, and company policies and procedures.

⛳️ Requirements

• In-depth, practical knowledge of managing audits within a Clinical Trials setting.

• Familiarity with GCP/ICH guidelines and FDA regulations and standards.

• Bachelor’s degree in a scientific, healthcare, or related discipline; a combination of qualifications and relevant experience may be considered as an alternative.

• Willingness to travel up to 25% domestically and/or internationally.

• A minimum of 2 years’ experience in a QA GCP department within a related industry (preferred).

• QA certification is preferred (e.g., CQA, SQA, etc.).

• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) is preferred.

🏝️ Benefits

• Flexible working arrangements.

• Paid time off.

• Opportunities for professional development.