qualitysenior
Clinical Quality Assurance / Auditor
Independent eyes on GCP compliance — sites, vendors, internal processes.
Also known as: GCP Auditor · Clinical QA Specialist
Salary band (US)
$110k–$175k
Salary band (UK)
£60k–£105k
Typical YoE
5–10 years (often ex-CRA)
What the role is
Clinical QA professionals plan and execute GCP audits of investigator sites, CROs, and internal sponsor processes; manage CAPAs; and prepare the organization for regulatory inspections (FDA BIMO, MHRA GCP, EMA). Q-IAOCR certification signals serious commitment to the auditing craft.
A typical day
- Pre-audit document review for a Phase III site audit
- On-site GCP audit at an investigator center
- CAPA review meeting with vendor
- Mock inspection prep for an upcoming BIMO
- Trend analysis on Q3 audit findings
Required skills
ICH-GCP auditCAPA designInspection readinessRisk-based auditingVendor qualification
Certifications that matter
Career ladder
Junior
QA Associate
This role
QA Auditor
Next
Senior Auditor → QA Manager → Head of QA
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