Associate Director Quality Assurance

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.

To find out more, apply here or message me directly for a confidential conversation.