GxP Auditor (Contract) – Global Clinical Trial Compliance

Tigermed; United States; On-site; USD 111,000 - 221,000; Full time

Job summary

Tigermed is seeking a contract-based GxP Audit Specialist to independently perform on-site and remote audits for Phase I-IV trials within the United States base region. The role requires strict adherence to ICH-GCP, FDA, EMA, TGA guidelines and robust document management.

Candidate must have a minimum of five years hands-on clinical trial/GxP audit experience, with strong local regulatory knowledge and excellent English report writing.

Qualifications

• Minimum 5 years of hands-on clinical trial/GxP audit experience.
• Experience in Australia, Europe or the US.
• Legal resident and based in United States.

Responsibilities

• Independently conduct on-site and remote GxP audits for local Phase I-IV trials.
• Draft professional English audit reports with clear findings and risk classifications; manage documentation.
• Coordinate CAPA follow-up and ensure closure of audit findings.

Skills

GxP auditing

Regulatory knowledge

Quality control

Stakeholder communication

Education

Bachelor’s degree

GCP certification

Job description

Tigermed is seeking a contract-based GxP Audit Specialist to independently perform on-site and remote audits for Phase I-IV trials within the United States base region. The role requires strict adherence to ICH-GCP, FDA, EMA, TGA guidelines and robust document management.

Candidate must have a minimum of five years hands-on clinical trial/GxP audit experience, with strong local regulatory knowledge and excellent English report writing.