Senior Quality Assurance Specialist

Senior Quality Assurance Specialist<p></p><p><span>ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</span></p><p></p><p></p><p></p><p></p><p><span><span>We are currently seeking a Senior Quality Assurance Specialist to join our dynamic team. You will play a critical role in ensuring and advancing quality across ICON’s Language Services department. Reporting to the Quality Management Team Lead, this role is responsible for the development, implementation, and continuous improvement of quality frameworks and methodologies that support regulatory compliance, client satisfaction, and operational excellence. </span></span></p><p></p><p><span><span>Combining deep expertise in localization and life sciences with strong analytical and strategic thinking, the Senior QA Specialist acts as both a quality guardian and a consultant — leading investigations, driving CAPA effectiveness, and shaping department-wide quality initiatives. This is a highly collaborative role interfacing with cross-functional teams, senior leadership, and ICON clients.</span></span></p><p><span> </span></p><p><b>What you will be doing:</b></p><p><span> </span></p><ul><li><p><span><span>Champion ICON’s values of People, Clients, and Performance by delivering quality solutions that align with regulatory and client expectations.</span></span></p></li><li><p><span><span>Oversee or lead the management of quality issues reported as client feedback or internal findings, ensuring timely, well-documented investigations and CAPA implementation.</span></span></p></li><li><p><span><span>Review and approve quality issue reports and client-facing communication to ensure transparency, accuracy, and alignment with industry standards.</span></span></p></li><li><p><span><span>Conduct root cause analyses and provide guidance on mitigation strategies to prevent recurrence and promote a learning culture.</span></span></p></li><li><p><span><span>Identify trends, risks, and recurring quality gaps through data analysis, translating findings into actionable quality improvement initiatives.</span></span></p></li><li><p><span><span>Act as a quality consultant within Language Services, advising operational and leadership teams on process design, localization best practices, and regulatory considerations.</span></span></p></li><li><p><span><span>Partner with stakeholders to develop and maintain meaningful, data-driven KPIs and dashboards to monitor service quality and process effectiveness.</span></span></p></li><li><p><span><span>Design and lead training sessions on quality methodologies, CAPA processes, and best practices in both quality and localization.</span></span></p></li><li><p><span><span>Contribute to the development and maintenance of controlled documentation, including SOPs, work instructions, and process maps.</span></span></p></li><li><p><span><span>Participate in internal and external audits, supporting audit readiness and follow-up activities.</span></span></p></li><li><p><span><span>Drive or support department-level strategic quality initiatives, including the evaluation of new tools, systems, or frameworks aimed at increasing quality, efficiency, and compliance.</span></span></p></li><li><p><span><span>Collaborate closely with operations, project management, vendor management, and client-facing teams to ensure consistent and integrated quality practices.</span></span></p></li></ul><p></p><p><b>Your Profile:</b></p><ul><li><p><span> </span><span><span>Minimum 7 years of experience in Quality Management within the localization industry, with a strong focus on life sciences or clinical research.</span></span></p></li><li><p><span><span>Proven expertise in quality issue investigation and CAPA management, including root cause analysis, <span>corrective/preventive</span> action planning, and effectiveness checks.</span></span></p></li><li><p><span><span>In-depth knowledge of localization workflows, linguistic QA, and tools such as memoQ, regex, and automated QA systems.</span></span></p></li><li><p><span><span>Strong understanding of GxP and clinical study processes, as well as regulatory requirements relevant to translation in the life sciences domain.</span></span></p></li><li><p><span><span>Familiarity with ISO 9001, 17100, and 18587 standards.</span></span></p></li><li><p><span><span>Experience working with QMS platforms and EDMS/document control systems.</span></span></p></li><li><p><span><span>Strong analytical skills and experience building and interpreting KPIs and quality metrics.</span></span></p></li><li><p><span><span>Excellent communication skills with the ability to translate complex quality and localization concepts to diverse stakeholders across the organization.</span></span></p></li></ul><p></p><p>#LI-RD1<span> </span></p><p>#LI-Remote</