Remote GCP Auditor — Independent QA Expert

Ergomed; San Francisco (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Ergomed Group in San Francisco seeks a skilled GCP Auditor to lead audits and ensure alignment with global regulatory standards. You will plan, conduct and report audits across sponsor and investigator sites, delivering high-quality assurance for pharmaceutical and biotech clients.

Ideal candidates have a Life Science degree and proven experience in both internal and external GCP audits, including mock inspections, with up to 40% travel and remote audit readiness.

Qualifications

• BSc in Life Science preferred.
• Experience leading internal and external GCP audits for diverse stakeholders.
• Experience auditing service providers (CROs, data management, etc.).
• Knowledge of national and international GCP legislation.

Responsibilities

• Plan, prepare, conduct, report and follow up on GCP audits according to quality and timelines.
• Execute audits based on regulatory requirements and Good Clinical Practice (GCP).
• Perform GCP quality assurance projects for client companies in pharma/biotech.
• Coordinate inspection preparation activities at sponsor and site levels.

Skills

GCP audits

Auditing leadership

Regulatory compliance

Quality assurance

Education

BSc in Life Science

Job description

Ergomed Group in San Francisco seeks a skilled GCP Auditor to lead audits and ensure alignment with global regulatory standards. You will plan, conduct and report audits across sponsor and investigator sites, delivering high-quality assurance for pharmaceutical and biotech clients.

Ideal candidates have a Life Science degree and proven experience in both internal and external GCP audits, including mock inspections, with up to 40% travel and remote audit readiness.