Team Lead, Software Quality Engineering (V&V)

Responsibilities

• Lead and manage day-to-day operations of the Software Quality Engineering (SQE) team, including coordination of onshore and offshore testing resources.
• Review project documentation and requirements to ensure testability, completeness, and alignment with quality standards.
• Collaborate with internal stakeholders to understand project requirements and identify potential risks with mitigation strategies.
• Assign testing tasks to SQEs, monitor productivity and performance, and provide guidance to maintain high testing standards.
• Manage resource allocation, effort estimation, and capacity planning for testing activities across multiple projects.
• Define test strategies and oversee creation and execution of test cases including functional, integration, and performance testing.
• Ensure traceability between requirements, test cases, and test documentation.
• Collaborate with developers and implementation teams to understand changes in new software releases and determine appropriate regression and functional testing coverage.
• Lead the creation, review, and maintenance of test documentation and quality procedures aligned with company standards.
• Establish and continuously improve QA processes, testing methodologies, and technology standards to enhance product quality and delivery efficiency.
• Drive root cause analysis (RCA) for defects and production issues, implementing corrective and preventive actions (CAPA).
• Ensure testing activities comply with regulatory standards including Good Clinical Practices (GCP).
• Monitor key performance indicators (KPIs) related to productivity, quality, and project delivery timelines.
• Support internal and external audits by providing documentation and responding to audit findings as required.
• Participate in the evaluation and adoption of new testing tools, technologies, and automation frameworks.
• Maintain testing environments and ensure appropriate IT infrastructure is available for testing teams.
• Contribute to departmental strategy and align operational execution with Clario's corporate goals.
• Manage strategic vendor relationships, including offshore SQE partners, and support departmental budget oversight.
• Promote a positive, collaborative work environment that encourages teamwork, continuous improvement, and professional development.
• What We Look For
• Bachelor's degree in Information Technology, Computer Science, or a related field
• Minimum 5 years of experience in software testing or quality assurance
• Minimum 2 years of experience leading testing teams or managing QA projects
• Advanced understanding of the Software Development Life Cycle (SDLC)
• Proven expertise in software testing methodologies, test case design, and defect management
• Experience with test automation frameworks and automation strategy implementation
• Strong knowledge of Agile development methodologies
• ISTQB Advanced Level Test Analyst or Test Manager certification preferred
• Experience working in regulated environments such as clinical research, healthcare, or life sciences preferred
• Strong analytical and problem-solving skills with the ability to lead root cause analysis and continuous improvement initiatives
• Excellent communication and stakeholder management skills
• Strong English communication skills (written and verbal)
• Ability to lead cross-functional collaboration across technical, operational, and clinical teams

Benefits

Additional Information

A hands-on leadership role with responsibility in managing employees, tasks and project deliverables for a team of SQEs with individuals located onsite and offshore. At Clario, part of Thermo Fisher Scientific, we are transforming the clinical trial landscape through innovative technology and data-driven solutions that accelerate life-saving treatments for patients around the world. The Software Quality Engineering (SQE) Manager plays a critical role in ensuring the quality, reliability, and compliance of software solutions used in clinical research. This role leads testing operations, manages global testing resources, and drives continuous improvement in quality assurance processes to support the successful delivery of high-impact technology solutions.

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