Quality Manager

About Yonalink:

Yonalink provides the missing link in clinical trials with technology that is purpose-built to stream and map up-to-date data, securely automating the transfer of patient data from Electronic Health Records (EHRs) to Electronic Data Capture (EDC) systems. Our SaaS solution is bringing new levels of speed, quality, and efficiency to clinical trial operations across the globe, simplifying the complexity of clinical data collection and validation, and enabling true scalability.

At its core, Yonalink is a top-tier EDC, powered by our EHR-to-EDC streaming capabilities. Our solution also includes integrated ePRO, eCOA, eConsent, eSource and many more innovative advantages.

What You Will Be Doing:

The Quality Manager is responsible for implementing and overseeing Yonalink’s Quality Management System (QMS). This role ensures that Yonalink EDC and Yonalink Connect development processes and practices successfully perform expected verification and validation tasks, and that all system releases are of high quality and compliant with required regulations. The position collaborates with the Yonalink product owner to ensure all release documentation is accurate and complete, and that releases are delivered on time. This position is part-time (2 days per week).

Responsibilities:

· Quality Control: Conduct audits, tests, and checks to ensure products, processes, or services meet quality standards and regulatory requirements.

· Documentation and Record-Keeping: Maintain accurate and up-to-date documentation related to quality control processes, including recording test results, documenting non-conformities, and updating SOPs.

· Process Improvement: Participate in process improvement initiatives to enhance quality, efficiency, and effectiveness.

· Training and Education: Provide training and support to employees on quality control procedures, standards, and best practices.

· QA Standards and Processes: Define QA standards and processes, plan and organize necessary test passes, help triage bugs, drive issues to resolutions, and keep the data system development team and QA manager informed of QA status.

· Process Improvements and Standardization: Make recommendations for process improvements and standardization.

Experience:

· Bachelor’s degree in computer science, engineering, or a related field, or equivalent experience.

· Minimum of 5 years of experience in clinical trials quality assurance.

· Demonstrated experience implementing software QA methodologies, tools, and processes.

· Practical experience with systems regulated by 21 CFR Part 11, ICH E6 (R2), GCP, and other applicable regulations.

· Self-motivated, proactive, and detail-oriented work style.

· Management experience preferred.

· Experience with EDC, EHR, eClinical and/or other Health IT systems preferred.

· Working knowledge of browser debugging tools and automated testing preferred.

· English as a mother tongue level is mandatory.

Join us at Yonalink to be part of a team that is transforming the future of clinical trials through innovative technology!