Associate Director Quality Assurance

Barrington James; Polska; A distancia; PLN 526.000 - 789.000; Jornada completa

Descripción de la vacante

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%.

Formación

• 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%).

Responsabilidades

• 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.

Conocimientos

Audit management

GCP QA

Regulatory knowledge

ICH-GCP E6(R2)/(R3)

Vendor/auditor experience

Travel readiness

Eastern Europe experience

Russian language (advantage)

Educación

Life Sciences / Pharmacy / Nursing degree

Descripción del empleo

Associate Director, Quality Assurance (GCP) - Eastern Europe | Fully Remote

Our client is a fast-growing, commercial-stage oncology biopharmaceutical company with two approved therapies and a late-stage pipeline in haematology. With multiple global registrational Phase III trials underway, they're looking for an experienced GCP QA leader to oversee the quality of their clinical sites and vendors across Eastern Europe.

This is a hands-on, high-impact role reporting directly to the VP of Quality. You'll own regional clinical quality during a pivotal period, as the company moves its lead programmes towards FDA and EMA approval.

What you'll be doing:

• Planning and conducting routine, risk-based and for-cause GCP audits of investigator sites across Eastern Europe
• Auditing CROs, central and bioanalytical laboratories, and other clinical vendors, including qualification audits
• Driving inspection readiness for sites and vendors ahead of FDA, EMA and other health authority inspections, including mock inspections and gap assessments
• Investigating findings, supporting CAPA development and checking that fixes are effective
• Trending audit findings and quality metrics to spot recurring risks
• Acting as a trusted QA partner to Clinical Operations, Regulatory Affairs and Pharmacovigilance
• Contributing to GCP SOPs, training and continuous improvement

What they're looking for:

• 10+ years in pharma, biotech or CRO, including at least 7 years in GCP Quality Assurance
• Strong hands-on experience auditing investigator sites, CROs and clinical vendors
• Experience on global Phase I-III clinical trials (oncology or haematology strongly preferred)
• Experience overseeing clinical studies in Eastern Europe
• In-depth knowledge of ICH-GCP E6(R2)/(R3) and global clinical regulations
• Inspection readiness, CAPA and root cause analysis experience
• Degree in Life Sciences, Pharmacy, Nursing or a related field
• Willingness to travel internationally (around 25-40%)
• Russian language skills are a strong advantage
• GMP or wider GxP experience is a bonus

Location:

Fully remote. You must be based in Eastern Europe, for example Poland, Czech Republic, Slovakia, Hungary, Romania, Bulgaria, the Baltics, Serbia, Moldova, Georgia or Armenia.