Senior GCP Process Auditor

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

📋 Description

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

• Offer oversight and specialized knowledge to quality and compliance efforts, aiding project teams throughout all phases of a clinical trial.

• Support the Quality Management System, which includes Standard Operating Procedures (SOPs), training, and Corrective and Preventive Actions (CAPA).

• Process and manage documentation for controlled documents.

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

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

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

• Coordinate and execute internal audits of quality systems.

• Manage and carry out investigator site audits.

• Organize and conduct audits of trial master files.

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

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

• Oversee and manage reported quality concerns and any related corrective and preventive actions.

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

• Maintain Quality & Compliance trackers, databases, metrics, and files.

• Adhere to relevant regulations and standards.

⛳️ Requirements

• Extensive experience in managing all varieties of audits, particularly Good Clinical Practice (GCP) Process Audits.

• Proficient understanding of GCP/ICH guidelines as well as FDA regulations and standards.

• Bachelor’s degree in a science, 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.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.