Associate Director - Quality Assurance (GCP),

Barrington James; Polska; Remote; PLN 284,000 - 415,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GCP Audits

CAPA management

Audit reporting

ICH-GCP

Regulatory knowledge

Education

Bachelor's degree Life Sciences

Job description

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, with a focus on sustainable improvements and effective oversight.
• The ability to work effectively with international teams across multiple functions and geographical regions.
• Willingness to undertake international travel, typically around 25–40%, depending on clinical programme requirements.

Relevant experience gained within pharmaceutical sponsors, biotechnology organisations or CROs will be considered, provided candidates can demonstrate substantial practical GCP auditing expertise, strong regulatory knowledge and the ability to operate effectively across international clinical development programmes.