Job Title

An established life sciences organisation is seeking an experienced Clinical Quality Assurance (GCP) professional to support and oversee quality activities across clinical development programmes. Reporting into senior Quality leadership, this role is responsible for ensuring clinical trials are conducted in compliance with applicable regulatory requirements, ICH GCP guidelines, and internal quality systems.The position plays a key role in maintaining and continuously improving the GCP quality system, leading audit activities, supporting regulatory inspections, and driving inspection readiness across clinical teams to ensure a state of continuous compliance.Key ResponsibilitiesAct as the GCP Quality subject matter expert, providing compliance guidance and QA support to assigned clinical teamsContribute to the development, implementation, and continuous improvement of GCP-related components of the Quality Management System (QMS)Support qualification and ongoing oversight of GCP service providers, including due diligence assessments and vendor performance reviewsPlan, schedule, and conduct GCP audits (investigator sites, CROs, laboratories, and internal systems) in line with the approved audit programmeLead and coordinate inspection readiness activities across clinical functionsSupport preparation, conduct, and follow-up of GCP regulatory inspections (e.g. FDA, EMA, MHRA)Author and manage GCP QA documentation, including deviations, CAPAs, and change controlsTrack and monitor CAPAs to closure, including effectiveness checksDevelop, review, and maintain SOPs, policies, work instructions, and training materialsSupport wider quality initiatives and continuous improvement activities as requiredExperience, Knowledge & Technical SkillsExtensive experience in Clinical Quality Assurance (GCP)Hands-on experience managing deviations, CAPAs, change controls, and electronic quality systemsStrong working knowledge of ICH GCP and global regulatory requirements (FDA, EMA, MHRA)Qualified and experienced GCP auditor, with experience auditing investigator sites, vendors, and systemsSolid understanding of clinical trial operations and documentation standards across the trial lifecycleExperience supporting or participating in regulatory authority inspectionsProven ability to write, review, and maintain SOPs and controlled quality documentsProficient with Microsoft Office and electronic systems such as eQMS, eDMS, LMS, and eTMFWillingness to travel domestically and internationally (approximately 10–20%)Key Competencies & BehavioursStrong attention to detail with a high level of accuracy and quality focusDemonstrates integrity, ethical judgement, and a strong compliance mindsetHighly organised, adaptable, and able to manage multiple prioritiesEffective problem solver with strong investigation and report-writing skillsExcellent written and verbal communication skillsAble to influence and collaborate with cross-functional and global stakeholdersComfortable operating in a fast-paced, evolving environmentIf interested, please apply below or send your application to We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.