Senior GCP Process Auditor

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

📋 Description

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

• Process and maintain documentation for controlled documents as necessary.

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

• Facilitate client/sponsor audits and provide support during regulatory inspections.

• Organize and carry out assessments of potential and contracted vendors, including vendor audits when necessary.

• Coordinate and perform internal audits of quality systems.

• Coordinate and conduct audits of investigator sites.

• Coordinate and conduct audits of trial master files.

• Participate in computer systems validation projects and oversee systems change control processes.

• Offer Quality Assurance consultation and support to assigned project teams, both internally and externally.

• Manage reported quality issues and the associated corrective and preventive actions.

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

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

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

⛳️ Requirements

• The ideal candidate should possess extensive working knowledge of managing all types of audits, especially Good Clinical Practice (GCP) Process Audits; candidates lacking this experience will not be considered.

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

• A Bachelor’s degree in a science, healthcare, or a related field of study; a combination of qualifications and 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 working hours

• Paid time off

• Remote work options