Clario
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.
What We Offer
Competitive compensation
Provident Fund & Gratuity
Flexible leave plans
Flexible work schedules
Engaging employee programs
Hybrid work environment
What You’ll Be Doing
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.
At Clario, part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.