Senior QA Auditor (GCP)

b Overview /b p As Senior Quality Assurance Auditor you will drive compliance across hVIVO by auditing processes, facilities and studies against SOPs and international guidelines. You will work with cross‑functional teams to verify the effectiveness of quality systems and to manage supplier and subcontractor audits as part of the GCP audit programme. The role includes hosting external sponsor audits and regulatory inspections, and training Trainee QA Auditors. This hands‑on position is based in Canary Wharf and is site‑based 2–3 days a week, offering a meaningful opportunity to shape quality governance in clinical trials. /p b Responsibilities /b ul li Plan and conduct audits of hVIVO processes, systems, facilities, studies and documents per audit plans /li li Audit low to medium risk suppliers remotely and high risk suppliers on site /li li Lead on-site audits of suppliers/subcontractors as required /li li Close out audits with corrective actions and oversee follow-up /li li Assess compliance with QMS and update actions accordingly /li li Maintain knowledge of current regulations and SOPs /li li Audit planning and documentation across all business areas (labs, clinical, data management, computer system validation) /li li Support hosting external sponsor audits and regulatory inspections /li li Provide QA reviews of SOPs and Master Forms within QuMas /li li Train and assess competency of Trainee QA Auditors and QA Auditors /li li Liaise with staff to determine audit scope and ensure supplier qualifications /li li Produce audit reports and conduct peer reviews of audit findings /li li Follow up on audit responses and CAPAs /li li Manage back room for sponsor/regulatory audits /li /ul b Key requirements /b ul li Auditing experience in suppliers, vendors, clinical sites and laboratories /li li Strong knowledge of GCP and GCP for laboratories /li li Working knowledge of GLP and GMP /li li Excellent communication across all levels /li li Pragmatic and diplomatic problem solving /li li Excellent attention to detail /li li GCP or GCP for laboratories experience in pharmaceutical or CRO /li li Quality assurance auditing and quality system experience /li /ul ul li communication skills /li li pragmatic/problem-solving /li li attention to detail /li li GCP /li li GCP for laboratories /li li GLP /li /ul