Senior GCP QA Lead – Eastern Europe Clinical Audits

Barrington James; Polska; A distancia; PLN 284.000 - 415.000; Jornada completa

Descripción de la vacante

Barrington James is seeking an experienced GCP Quality Assurance professional based in Eastern Europe to lead audits of investigator sites and CROs across the region. The role emphasizes regulatory compliance, CAPA, and inspection readiness, with substantial international travel.

You will partner with Clinical Operations, Regulatory Affairs and external providers to ensure data integrity and patient safety, delivering practical guidance and robust quality controls in a matrix organization.

Formación

• Bachelor's degree in Life Sciences or related field; postgraduate degree advantageous.
• 10+ years in pharma/biotech/CRO with at least 7 in GCP QA.
• Hands-on GCP audits of investigator sites, CROs, and vendors.
• Global Phase I–III trial experience, oncology preferred.
• Auditing Eastern Europe sites and vendors.
• Inspection readiness, CAPA, root-cause, risk assessment expertise.
• ICH-GCP knowledge including E6(R2/R3).
• Translate regulations into practical quality controls and remediation plans.
• Strong stakeholder management and cross-functional influence.
• Excellent written and verbal audit reporting skills.

Responsabilidades

• Plan and conduct GCP audits of investigator sites across Eastern Europe.
• Assess compliance with ICH-GCP, protocols, informed consent, safety, data integrity.
• Identify findings, support CAPA, and verify effectiveness of corrective actions.
• Partner with Clinical Operations to resolve site issues and maintain inspection readiness.
• Audit CROs, central laboratories, bioanalytical labs, and other service providers.
• Evaluate vendor QMS, regulatory compliance, deviation management and CAPA.
• Develop risk-based vendor oversight strategies with Clinical Operations.
• Monitor remediation activities and escalate significant quality concerns.
• Support health authority inspections (FDA and EMA).
• Conduct mock inspections, gap assessments and readiness reviews.
• Review audit outcomes, quality events, deviations and trends to identify systemic issues.
• Contribute to GCP SOPs, work instructions and training materials.
• Provide practical GCP guidance to Clinical Operations, Regulatory Affairs and external partners.
• Support Quality by Design principles and risk-based QMS across development programmes.

Conocimientos

GCP Audits

CAPA management

Audit reporting

ICH-GCP

Regulatory knowledge

Educación

Bachelor's degree Life Sciences

Descripción del empleo

Barrington James is seeking an experienced GCP Quality Assurance professional based in Eastern Europe to lead audits of investigator sites and CROs across the region. The role emphasizes regulatory compliance, CAPA, and inspection readiness, with substantial international travel.

You will partner with Clinical Operations, Regulatory Affairs and external providers to ensure data integrity and patient safety, delivering practical guidance and robust quality controls in a matrix organization.