Senior Quality Assurance Specialist - Office or Homebased - Poland, Spain or United Kingdom
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.
Job profile summary:
The Senior Quality Assurance Specialist plays 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. 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.
Job description:
· Champion ICON’s values of People, Clients, and Performance by delivering quality solutions that align with regulatory and client expectations.
· Oversee or lead the management of quality issues reported as client feedback or internal findings, ensuring timely, well-documented investigations and CAPA implementation.
· Review and approve quality issue reports and client-facing communication to ensure transparency, accuracy, and alignment with industry standards.
· Conduct root cause analyses and provide guidance on mitigation strategies to prevent recurrence and promote a learning culture.
· Identify trends, risks, and recurring quality gaps through data analysis, translating findings into actionable quality improvement initiatives.
· Act as a quality consultant within Language Services, advising operational and leadership teams on process design, localization best practices, and regulatory considerations.
· Partner with stakeholders to develop and maintain meaningful, data-driven KPIs and dashboards to monitor service quality and process effectiveness.
· Design and lead training sessions on quality methodologies, CAPA processes, and best practices in both quality and localization.
· Contribute to the development and maintenance of controlled documentation, including SOPs, work instructions, and process maps.
· Participate in internal and external audits, supporting audit readiness and follow-up activities.
· Drive or support department-level strategic quality initiatives, including the evaluation of new tools, systems, or frameworks aimed at increasing quality, efficiency, and compliance.
· Collaborate closely with operations, project management, vendor management, and client-facing teams to ensure consistent and integrated quality practices.
· Other duties as assigned.
Requirements:
· Minimum 7 years of experience in Quality Management within the localization industry, with a strong focus on life sciences or clinical research.
· Proven expertise in quality issue investigation and CAPA management, including root cause analysis, corrective/preventive action planning, and effectiveness checks.
· In-depth knowledge of localization workflows, linguistic QA, and tools such as memoQ, regex, and automated QA systems.
· Strong understanding of GxP and clinical study processes, as well as regulatory requirements relevant to translation in the life sciences domain.
· Familiarity with ISO 9001, 17100, and 18587 standards.
· Experience working with QMS platforms and EDMS/document control systems.
· Strong analytical skills and experience building and interpreting KPIs and quality metrics.
· Excellent communication skills with the ability to translate complex quality and localization concepts to diverse stakeholders across the organization.
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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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