How You Will Contribute

In this position, you will be working with our Clinical Research team. For more information, please visit ITC I Red Nucleus.

Job Overview

The QA Lead serves as the foundational quality leader for iTakeControl and a key contributor to the evolution of Quality Assurance practices across Red Nucleus.

You will own end-to-end QA for iTakeControl, a clinical trial patient engagement platform operating within a validated GxP-compliant environment, while simultaneously establishing and leading QA capabilities that support broader product and delivery initiatives across the organization. This is a dual-scope role combining hands-on quality ownership, team leadership, and functional capability building.

You bring deep testing expertise along with the ability to build, mentor, and scale QA talent. You will define and execute QA strategy for iTakeControl, hire and develop dedicated QA resources, and provide leadership and guidance to QA team members working across other Red Nucleus initiatives. Over time, you will help establish consistent testing standards, tooling, and best practices aligned to regulatory expectations and scalable delivery.

You are joining at a pivotal phase as iTakeControl transitions from external vendor ownership to a fully in-house model. Automated testing assets and validation documentation are in place. Your initial priority is to assess and operationalize these materials within the context of a live, regulated system, and establish a sustainable, high-quality testing approach. From there, you will expand test coverage, strengthen validation rigor, and drive continuous improvement in quality processes.

More broadly, you will act as a QA leader across the organization supporting resource alignment, mentoring QA engineers across projects, and contributing to a unified approach to quality in clinical and digital solutions.

The role requires close collaboration with US and Morocco-based stakeholders, product managers, and engineering leadership, with extended overlap during key releases and transition milestones.

Core Responsibilities

QA and Validation Ownership

- Own the long-term quality health of the iTakeControl platform, including test strategy, coverage, validation documentation, and team delivery
- Establish and lead QA capabilities and team members that support broader product and delivery initiatives across the organization
- Assess and extend the inherited automated test suite to close compliance-critical coverage gaps
- Prepare and maintain validation documentation (IQ/OQ/PQ) in line with GxP, HIPAA, and FDA 21 CFR Part 11 requirements




- Ensure test scripts, execution records, and traceability matrices are completed iteratively per story not as a release-end batch
- Define and enforce QA standards, test artefact quality expectations, and release readiness criteria
- Maintain clear, current QA documentation including test plans, test cases, defect reports, and validation packages in Confluence
- Conducts responsive design and accessibility testing (WCAG) to ensure web-based solutions meet usability and compliance standards across devices and screen sizes

Hands-On Test Design and Execution

- Design and execute comprehensive test plans covering functional, regression, integration, and end-to-end scenarios across a modern React / Node.js web application and native iOS and Android mobile applications
- Apply exploratory testing techniques to identify negative scenarios, boundary conditions, and edge cases beyond scripted cases
- Verify compliance-critical functionality: audit logging, electronic signatures, ALCOA+ data integrity, and a role-based access control system with multiple user roles and granular permissions
- Validate clinical workflows including assessment window timing, eConsent flows, diary submissions, Rating Portal scorecards, and video recording, playback, and blur processing
- Manage defect lifecycle clearly documented, prioritised, and resolved; verify fixes and maintain defect traceability
- Participate in requirements review early in the development cycle and collaborate with product managers during UAT to ensure features meet acceptance criteria before validation

Test Automation and Tooling

- Build, maintain, and expand automated test suites using Playwright (e2e and visual regression) and Vitest (unit and integration)
- Integrate automated tests into GitLab CI/CD pipelines in collaboration with the DevOps engineer; enforce test gates on all deployments
- Identify automation opportunities and bottlenecks in the test-to-release pipeline; guide the team on tooling selection and usage

Team Leadership and Development

- Recruit, onboard, and manage QA engineers; own day-to-day technical guidance, 1:1s, and performance input
- Act as mentor and coach for QA team members; conduct peer reviews of test artefacts with clear,



constructive feedback
- Share knowledge through team sessions and documentation to raise the teams overall capability
- Establish and document best practices and testing standards for the team to follow
- Lead internal QA process improvement initiatives; identify efficiencies in QA workflows and tooling
- Collaborate with the Technical Lead on architectural decisions that impact testability, observability, and compliance

Compliance, Validation, and Regulated Environment

- Work within the existing validated GxP system following change control processes for all test environment changes and validation updates
- Ensure ALCOA+ data integrity and complete audit trails are verifiable every create, update, and delete on clinical data must be captured
- Lead IQ/OQ/PQ preparation and execution in collaboration with the Technical Lead and product managers
- Ensure compliant post-deployment verification and regression confirmation following each release
- Maintain strict multi-study/multi-tenant data isolation and understand the regulatory implications of any cross-study data exposure

Required Technical Expertise

Core Technical Skills

- Playwright hands-on experience writing and maintaining e2e and visual regression tests for web applications
- Vitest or equivalent experience with up-to-date JavaScript test frameworks (Vitest, Jest, Mocha) for unit and integration testing
- Experience testing native or hybrid mobile applications on iOS and Android functional testing, device/OS compatibility, and regression across supported versions
- Solid understanding of React / Node.js applications from a testing perspective; ability to read application code to write meaningful tests
- RESTful API and JSON-RPC testing; experience validating JWT authentication flows and that RBAC permission checks are correctly enforced
- MySQL for test data management, verification queries, and audit trail inspection
- Git workflows and experience integrating tests into GitLab CI/CD pipelines
- Performance and load testing working knowledge of tools such as k6 or JMeter; able to identify bottlenecks, validate throughput under concurrent load, and coordinate findings with developers
- AWS S3 validating file upload, storage, and retrieval workflows including presigned URL patterns for participant video access

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 QA Lead iTakeControl (Pune)
🏢 Red Nucleus
📍 Pune