Assignment Description

Our client is currently seeking a Quality Assurance Lead – Study Upgrades. The Quality Assurance Lead – Study Upgrades is responsible for leading the validation and testing activities related to product upgrades and the support of clinical studies using Unify, a clinical trial solution co-designed by patients and healthcare professionals to streamline the trial experience and digitize clinical trials. Working closely with the Study Upgrades team and the BA team, the Quality Assurance Lead analyzes the upgrade scope and its impact on live studies, defines upgrade test coverage, and ensures the overall quality of upgrades. Effective communication and cultural sensitivity are key, as the role requires interactive collaboration.

Additionally, the Quality Assurance Lead leads the process and workflow improvements to enable scalability and support a growing number of clinical trials.

Main Responsibilities:

• Team Leadership: Provide guidance to the QA team involved in study upgrades, ensuring the successful delivery of a high-quality product. Take the main person responsible for the successful validation and test of study upgrades, prioritizing ongoing support for the team. In addition, be part of refining and optimizing the testing upgrades QA process, addressing any process blockers that may arise. Collaborate closely with other teams to facilitate successful upgrade releases.
• Impact Assessment and Configuration Changes Analyses: Analyze upgrade specifications and collaborate with the BA team to understand the scope of the upgrade and its impact on existing studies. Analyze the scope of the upgrade, understand the changes made to the system configuration, and lead the test cases and test coverage process to cover the changes delivered during upgrades.
• Validation and Test of the Product Configuration: Coordinate the execution of test cases and oversee and be part of the testing activities to verify the quality and functionality of study upgrades. Ensure that existing functionalities are not impacted by the configuration changes by conducting regression testing.
• Risk Management: Identify and mitigate risks associated with study upgrades on the quality side, proactively addressing potential issues to minimize impact on project timelines and deliverables.
• Defect Management: Manage the identification, tracking, and resolution of defects encountered during testing, ensuring timely resolution and communication with relevant stakeholders.
• Documentation: Ensure thorough documentation of QA activities, including test plans, test reports, traceability matrix, and any additional documentation to support project documentation and audit requirements.
• Process Improvement: Provide feedback on the testing process and suggest improvements to streamline Configuration Verification and Test activities for future study upgrades.

Required Skills & Experience:

• 7+ years of experience in software quality assurance, with 2 years in a leadership role
• Solid understanding of quality assurance theory, terminology, and strategies
• Proficiency in test planning, test case design, and test execution
• Experience with test management tools and defect tracking systems
• Excellent communication and interpersonal skills, with the ability to effectively lead and collaborate with cross-functional teams
• Experience in mentoring and coaching team members, providing guidance and support to ensure quality deliverables
• Mobile testing experience
• Experience in working with HTTP Proxy Tool
• Experience with Test management System as XRay
• Understanding of REST APIs
• Experience in web-services testing
• Experience with Integration Testing
• Proactive attitude towards learning and problem-solving, excellent communication skills, demonstrated ability to work with both technical and non-technical individuals
• Excellent task management skills and task prioritization

Desired Skills & Experience:

• Degree in relevant discipline or formal certification in quality assurance practice
• Experience from Healthcare and Life Sciences, preferably with clinical trials
• Experience of working in a global organization with complex/geographical context
• Experience of working in a regulated environment, ideally, GxP/SaMD experience
• Knowledge of automation testing tools and experience supporting automation tests

Additional Information Specifically for This Job Request:

• Study Onboarding QA Team: Requirement Analysis, Test Planning, Test Case Design and Execution, Defect Management, and Risk Assessment. Maintain the Upgrades documentation as test plans and test reports.
• Study Onboarding BA Team: Collaboration on requirements analyses and impact assessment on the upgrade.
• Study Onboarding PM Team: Collaborate with the PM team on planning and defect prioritization and upgrade dependencies.
• SMEs: Engineering teams on case analysis and resolution.
• Product owners and business analysts: To understand existing functionalities.

Language:

• Fluent English
• Swedish – Good to have