Senior GCP Process Auditor

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

📋 Description

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

• Offer oversight and expert knowledge in quality and compliance efforts

• Support project teams throughout all phases of a clinical trial

• Create and deliver training for staff and/or consultants

• Facilitate client/sponsor audits and aid in regulatory inspections

• Organize and perform evaluations of potential and contracted vendors, including vendor audits as necessary

• Organize and execute internal audits of quality systems

• Coordinate and carry out investigator site audits

• Manage and conduct trial master file audits

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

• Provide quality assurance 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

⛳️ Requirements

• Comprehensive, practical knowledge of managing various types of audits, especially GCP Process Audits

• 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% both domestically and/or internationally

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development