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.
