Associate Director

The successful candidate must be based in Eastern Europe, with a strong preference for individuals with established experience supporting clinical trials across the region. Russian-language skills would be advantageous. The position involves approximately 25–40% international travel.

Working arrangement: Remote working may be possible, subject to confirmation of the approved country of residence and employment arrangements.

Responsibilities

• Plan and conduct routine, risk-based and for-cause GCP audits of investigator sites, with a particular focus on clinical trial activities across Eastern Europe.
• Assess compliance with ICH-GCP, clinical protocols, informed consent requirements, patient safety obligations, data integrity standards and essential clinical trial documentation.
• Identify audit findings and emerging quality risks, support root cause investigations, contribute to CAPA development and conduct follow-up assessments to verify the effectiveness of corrective and preventive actions.
• Partner with Clinical Operations to resolve site-level compliance issues, strengthen quality oversight and maintain inspection readiness throughout the clinical trial lifecycle.
• Conduct qualification, routine and for-cause audits of CROs, central laboratories, bioanalytical laboratories and other external service providers supporting clinical development programmes.
• Evaluate vendor quality management systems, operational processes, regulatory compliance, deviation management, audit findings and CAPA implementation.
• Develop risk-based vendor oversight strategies in collaboration with Clinical Operations and relevant vendor management teams.
• Monitor vendor remediation activities, assess the effectiveness of corrective actions and elevate significant or recurring quality concerns.
• Support inspection readiness across clinical sites and external service providers, including preparation for health authority inspections involving agencies such as the FDA and EMA.
• Conduct mock inspections, quality gap assessments and readiness reviews, ensuring relevant documentation, processes and supporting evidence are appropriately maintained.
• Review and trend audit outcomes, quality events, deviations and compliance metrics to identify recurring issues, assess systemic risks and recommend improvements.
• Contribute to the development and maintenance of GCP standard operating procedures, work instructions, training materials and continuous improvement initiatives.
• Provide practical GCP compliance guidance to Clinical Operations, Regulatory Affairs, Pharmacovigilance and external service providers, supporting effective resolution of quality issues.
• Support Quality by Design principles and risk-based quality management across clinical development programmes, with an emphasis on patient protection, data reliability and regulatory compliance.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, Nursing or a related scientific discipline. A postgraduate or other relevant advanced degree would be advantageous.
• More than 10 years of experience within the pharmaceutical, biotechnology, CRO or regulatory environment, including at least seven years in GCP Quality Assurance.
• Demonstrable hands-on experience conducting GCP audits of investigator sites, CROs and external clinical service providers.
• Experience supporting global Phase I–III clinical trials, ideally within oncology or another complex therapeutic area.
• Experience auditing or overseeing clinical trial sites and external vendors across Eastern Europe, with an understanding of regional operational practices and clinical research requirements.
• Practical experience conducting laboratory audits, including assessments of central laboratories, bioanalytical laboratories and other specialist providers involved in clinical research.
• Strong experience in inspection readiness, CAPA management, root cause analysis, audit reporting and quality risk assessment.
• Detailed knowledge of ICH-GCP, including E6(R2) and E6(R3), and the regulatory requirements governing international clinical trials.
• The ability to translate regulatory expectations into practical quality controls, risk mitigation measures and effective remediation plans.
• Strong stakeholder management skills, with the confidence to influence cross-functional teams, challenge non-compliant practices and communicate quality risks effectively within a matrix organisation.
• Excellent written and verbal communication skills, including the ability to produce clear audit reports, explain complex compliance issues and provide constructive guidance to internal teams and external partners.
• A pragmatic, analytical and risk-based approach to Quality Assurance, w