Senior GCP QA Lead, Remote (Eastern Europe) – Oncology Trials

Barrington James

Polska

Remote

PLN 526,000 - 789,000

Full time

30 hours ago

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Job summary

Barrington James is seeking an Associate Director of Quality Assurance (GCP) for Eastern Europe, fully remote. You will lead regional clinical quality for Phase I-III oncology/haematology trials, auditing sites, CROs and vendors, and driving inspection readiness across the region.

The role requires 10+ years in pharma/biotech/CRO with 7+ in GCP QA, strong auditing hands-on experience, and the ability to travel 25–40%.

Qualifications

10+ years in pharma/biotech/CRO with 7+ years in GCP Quality Assurance.
Hands-on audits of investigator sites, CROs and clinical vendors.
Experience on global Phase I-III oncology/haematology trials preferred.
Experience overseeing studies in Eastern Europe.
In-depth knowledge of ICH-GCP E6(R2)/(R3) and global regulations.
Travel internationally (roughly 25–40%).

Responsibilities

Plan and conduct routine, risk-based and for-cause GCP audits across Eastern Europe.
Audit CROs, central and bioanalytical labs and other vendors, including qualification audits.
Drive inspection readiness for FDA/EMA inspections with mock inspections and gap assessments.
Investigate findings, support CAPA development and verify fixes.
Trend audit findings and quality metrics to identify recurring risks.
Act as QA partner to Clinical Operations, Regulatory Affairs and Pharmacovigilance.
Contribute to GCP SOPs, training and continuous improvement.