Senior Localization Quality Specialist

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

Reporting into the Quality Management Lead within ICON Language Services, the Senior Quality Process Specialist will be responsible for architecting, creating and maintaining the Quality Framework and Management System, enabling the continuous improvement of Language Services across the organization and / or Sponsors. The person will be expected to engage with various stakeholders including the Customers and ICON’s senior management.

Responsibilities:

• Partner with the key stakeholders to develop, maintain and produce metrics to monitor the quality of the deliverables and services.

• Act as a consultant within ICON Language Services and advise the best solutions to improvement the overall quality.

• Analyze data to identify the key improvement areas and recommend solutions to the relevant stakeholders.

• Develop and execute strategic quality projects.

• Oversee or own the management of Quality Issues and CAPA.

• Educate the business, at all levels in the organization, on all quality related processes and best practices.

• Coordinate the internal and external audits and qualification activities.

• Validates the completion and effectiveness of any improvement actions implemented by the Production teams.

• Help architect custom solutions for new services and the governance of the quality metrics and attributes.

• Communicate clearly and effectively with all levels of the business (internally and externally).

• Act as a Business Partner to other ICON departments, especially the Global Quality and Compliance team.

What you need?

• Extensive experience in Localization Quality Management of Life Science domain, including LQA and CAPA

• Experience with Localization Tools, Technologies and Best Practices

• Ability to investigate a complex quality issue, including Root Cause Analysis and CAPA report writing

• Knowledge and application of Continuous Improvement methodology

• Experience working with ISO9001, ISO17100 and ISO18587 standards

• Knowledge of Clinical Study Regulations and GxPs

• Strong data analysis and problem-solving skills

• Excellent communication skills, with the ability to simplify and explain complex problems to stakeholders of all levels across multiple functions.

• Experience with QMS