Senior Quality Assurance Manager

Senior Quality Assurance (QA) Manager – Clinical TrialsWe are seeking an experienced and motivated Senior Quality Assurance (QA) Manager – Clinical Trials, with a focus on the GCP-regulated environment, to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.Key ResponsibilitiesPlan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)Ensure compliance with GCP, ICH guidelines, FDA regulations, and applicable regulatory requirements, and company standardsOwn and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checksDrive risk management activities, including risk assessments and mitigation strategiesLead and support change management processes related to quality systems and clinical operationsResponsible for the creation, review, approval, and lifecycle management of QA SOPsPreparation of role-based training materials and conduct of training courses in the GCP/FDA regulated settingPrepare quality metrics, management reports, and audit summaries for upper managementAct as a key QA contact for regulatory inspections and sponsor auditsCollaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partnersSupport continuous improvement initiatives within the Quality Management System (QMS)Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systemsQualifications & ExperienceUniversity degree in Life Sciences, Pharmacy, Medicine, or a related fieldSeveral years of professional experience in Quality Assurance within clinical trials, ideally within a GCP regulated environmentFamiliarity with clinical trial processes across Phases I-III.Senior QA professionalStrong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)Act as the GCP Quality Assurance expert and primary point of contact for GCP compliance matters in global and multi-regional clinical trials.Demonstrated experience in:Audit planning and inspection readiness, performance, and reportingDeviation and CAPA managementRisk managementChange managementSOP and training managementWillingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USAStrong organizational, analytical, and problem-solving skillsConfident communication style and ability to work with stakeholders at all levelsWhat We OfferA responsible senior role in an international clinical research environmentHigh level of autonomy and the opportunity to actively shape QA processesCollaboration with global teams and exposure to international projectsA thorough and practice-oriented onboardingPerformance-based compensation and flexible working hoursA company culture strongly characterized by trust and collegialityAn exciting workplace with opportunities for professional and personal development, for example development into a team lead function