Team Lead, Software Quality Engineering (V&V)

Responsibilities

• Lead and manage the day‑to‑day operations of the Software Quality Engineering (V&V) team, including coordination of onsite and offshore testing resources.
• Provide hands‑on leadership for a team of SQEs, overseeing task assignment, delivery commitments, productivity, and performance.
• Review project documentation and requirements to ensure testability, completeness, and alignment with quality, validation, and regulatory standards.
• Collaborate closely with Product, Engineering, Clinical, and Implementation teams to understand requirements, identify risks, and define mitigation strategies.
• Define overall V&V and test strategies and oversee the creation, execution, and maintenance of functional, integration, regression, and performance test cases.
• Ensure full traceability between requirements, test cases, defects, validation evidence, and test documentation.
• Partner with development teams to assess changes in new software releases and determine appropriate testing and validation scope and coverage.
• Drive root cause analysis (RCA) for defects and production issues, implementing corrective and preventive actions (CAPA).
• Establish, maintain, and continuously improve QA/V&V processes, testing methodologies, and quality standards.
• Monitor and report on key performance indicators (KPIs) related to quality, productivity, validation status, and delivery timelines.
• Support internal and external audits by providing required validation documentation and responding to audit observations.
• Evaluate and support the adoption of testing tools, automation frameworks, and emerging QA/V&V technologies.
• Manage testing and validation environments and ensure appropriate IT infrastructure is available.
• Contribute to departmental strategy and align execution with Clario's corporate and quality objectives.
• Manage strategic vendor relationships, including offshore SQE partners, and support departmental budget oversight.
• Foster a collaborative, inclusive, and high‑performance team culture focused on continuous improvement and professional development.
• Provide performance feedback and input into employee development and appraisal processes.
• What We Look For
• Bachelor's degree in Biomedical Engineering, Electronics, Computer Science, or a related discipline.
• Minimum 5 years of experience in software testing, validation, or quality assurance.
• Minimum 2 years of experience leading QA/V&V teams or managing testing projects.
• Experience working in regulated environments such as clinical research, healthcare, or life sciences.
• Strong understanding of the Software Development Life Cycle (SDLC) and Agile development methodologies.
• Proven expertise in software testing methodologies, test case design, defect management, and validation documentation.
• Experience defining and implementing test automation strategies and frameworks.
• Solid knowledge of Good Clinical Practices (GCP) and regulatory compliance expectations.
• ISTQB Advanced Test Analyst or Test Manager certification preferred.
• Strong analytical, problem‑solving, and decision‑making skills.
• Excellent stakeholder management and communication skills.
• Strong English written and verbal communication skills.
• Ability to lead cross‑functional collaboration across technical, operational, and clinical teams.

Benefits

Additional Information

Clario, a part of Thermo Fisher Scientific, is a global leader in endpoint technology solutions for clinical trials. We are seeking a hands‑on Team Lead, Software Quality Engineering (V&V) to lead and scale our eCOA Software Quality team in Bangalore. This role combines people leadership, technical verification and validation oversight, and cross‑functional collaboration to ensure high‑quality, compliant software delivery in a regulated clinical environment.

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