Senior GCP Process Auditor

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

📋 Description

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

• Process and uphold documentation for controlled documents as needed.

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

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

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

• Coordinate and execute internal audits of quality systems.

• Manage and carry out investigator site audits.

• Oversee and conduct audits of trial master files.

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

• Offer Quality Assurance (QA) consultation and support to designated project teams both internally and externally.

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

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

• Maintain Quality & Compliance (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 guidelines, and company policies and procedures.

⛳️ Requirements

• In-depth, practical understanding of managing all forms of audits, especially Good Clinical Practice (GCP) Process Audits.

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

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

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

• Experience in a Contract Research Organization (CRO) is preferred.

• QA certification is favored (e.g., Certified Quality Auditor (CQA), Supplier Quality Assurance (SQA), etc.).

• Background in electronic clinical trial systems (e.g., Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Interactive Response Technology (IxRS), electronic Patient Reported Outcomes (ePRO), etc.).

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Opportunities for professional development.