Senior GCP Process Auditor

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

📋 Description

• Assist in the audit program and clinical projects to guarantee adherence to regulations and Precision procedures.

• Provide oversight and expert knowledge to quality and compliance operations.

• Support project teams throughout all phases of a clinical study.

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

• Process and manage documentation for controlled documents as necessary.

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

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

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

• Coordinate and execute internal audits of quality systems.

• Oversee and conduct audits of investigator sites.

• Manage and execute trial master file audits.

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

• Offer QA consultation and support to designated project teams, both internally and externally.

• Address and oversee reported quality issues along with any related corrective and preventive actions.

• Monitor quality systems to provide insights on compliance risks to QA management and identify areas for enhancement.

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

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

⛳️ Requirements

• Extensive hands-on experience in managing all types of audits, especially GCP Process Audits.

• Solid understanding of GCP/ICH guidelines and FDA regulations and standards.

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

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

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options