Senior GCP Process Auditor

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

📋 Description

• Assist in the implementation of the Quality Management System, including standard operating procedures (SOPs), training, and corrective and preventive actions (CAPA).

• Process and maintain the documentation for controlled documents as necessary.

• Design and deliver training programs for employees and/or consultants.

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

• Organize and perform evaluations of potential and contracted vendors, including conducting vendor audits as needed.

• Organize and execute internal audits of quality systems.

• Coordinate and carry out investigator site audits.

• Coordinate and conduct audits of trial master files.

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

• Provide quality assurance consultation and support to project teams both internally and externally.

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

• Monitor quality systems to give feedback on compliance risks to QA management and pinpoint opportunities for enhancements.

• Maintain quality and compliance trackers, databases, metrics, and documentation.

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

⛳️ Requirements

• The preferred candidate will possess extensive practical knowledge in managing various types of audits, particularly GCP Process Audits; candidates lacking this experience cannot be considered.

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

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

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

• Experience in a Contract Research Organization (CRO) setting.

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

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

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Budget for professional development.

• Allowance for home office setup.

• Opportunities for global team events.