Red Nucleus is hiring a Senior QA Engineer - iTakeControl to join our global team. This role will be fully onsite at our Pune office.There may be flexibility to transition to a hybrid work model in the future, based on business requirements.
Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.
At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".
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 Senior QA Engineer is a hands-on quality leader responsible for owning and growing the quality assurance function for iTakeControl, a clinical trial patient engagement platform operating within a validated GxP-compliant environment.
You will be joining at an exciting phase: the platform is transitioning from an external vendor to full in-house ownership. An automated test suite and the validation documentation are already in place. Your first priority is to understand what exists, assess it against the compliance requirements of a live clinical system, and take ownership of quality from that point forward. Over time, you will shape the QA strategy, expand test coverage, and establish the standards the team works towards as the platform grows.
The role requires regular collaboration with US-based stakeholders and product managers, with extended overlap during critical releases.
Core Responsibilities
Quality Ownership and Compliance
- Own the long-term quality health of the iTakeControl platform, including test strategy, coverage, and validation documentation
- Assess and extend the inherited automated test suite — covering backend integration, end-to-end, and visual regression scenarios — to close compliance-critical coverage gaps
- Prepare, lead, and maintain IQ/OQ/PQ validation activities and documentation 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 or feature — not as a release-end batch
- Maintain clear, current QA documentation including test plans, test cases, defect reports, and validation packages in Confluence
- Work strictly within the existing validated GxP-compliant system, preserving validation status and following change control processes for all test environment changes
- Ensure ALCOA+ data integrity principles and complete audit trails are maintained and verifiable — this includes verifying that the platform's audit log captures all creates, updates, and deletes on clinical data
- 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
- Act as the QA point of accountability for the product within approved compliance boundaries
Test Design, Execution and Automation
- 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
- Go beyond happy-path testing — proactively identify negative scenarios, boundary conditions, and edge cases relevant to clinical trial workflows
- Verify compliance-critical functionality including audit logging, electronic signatures, ALCOA+ data integrity, and a complex role-based access control system with multiple user roles and granular permissions
- Build, maintain, and expand automated test suites using Playwright as the primary e2e and visual regression framework, and Vitest for unit and integration tests
- Integrate automated tests into CI/CD pipelines (GitLab CI) in collaboration with the DevOps engineer; ensure test gates are enforced on all deployments
- Champion the adoption of AI-assisted QA tooling (e.g., Claude Code) to accelerate test case generation, coverage analysis, and documentation authoring
- Identify bottlenecks in the test-to-release pipeline and propose tooling or process improvements to reduce cycle time without compromising quality
- Collaborate with product managers during sandbox reviews and UAT to ensure features meet acceptance criteria before validation
- Participate in requirements review early in the development cycle to provide QA input and prevent defects upstream
- Troubleshoot and triage defects, working closely with developers to reproduce, document, and verify fixes
Technical Direction and Mentorship
- Define and enforce QA standards, testing practices, documentation expectations, and release readiness criteria
- Provide guidance and mentorship to junior QA and full-stack engineers on quality practices, test design, and regulated system requirements
- Collaborate with the Tech Lead on architectural decisions that impact testability, observability, and compliance
- Proactively identify quality risks, gaps in test coverage, and improvement opportunities and drive resolution
Required Technical Expertise
Core Technical Skills
- Playwright — hands-on experience writing and maintaining Playwright tests for web applications, including end-to-end and visual regression scenarios
- Vitest or equivalent — experience with modern 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 and quality perspective; ability to read and understand the application code to write meaningful tests
- Experience designing automated test frameworks for complex, multi-layer web applications; ability to extend an inherited suite without breaking existing coverage
- Familiarity with RESTful API testing and JSON-RPC backend patterns; experience testing authentication flows (JWT, role-based access) and validating that permission checks are correctly enforced
- Working knowledge of MySQL for test data management, verification queries, and audit trail inspection
- Strong Git workflows and experience integrating tests into GitLab CI/CD pipelines
- Comfort using AI-assisted development and testing tools (e.g., Claude Code, GitHub Copilot) for test generation, coverage analysis, and documentation authoring
Regulatory and Compliance Knowledge
- Experience working in GxP-regulated, FDA-regulated, or HIPAA-compliant software environments
- Practical understanding of IQ/OQ/PQ validation lifecycle and preparation of validation documentation packages
- Familiarity with ALCOA+ principles and their application to test evidence, audit trail requirements, and clinical data records
- Familiarity with FDA 21 CFR Part 11 requirements for electronic records and signatures
- Understanding of clinical data handling principles: data integrity, participant privacy, role-based data access, and what constitutes a protocol deviation
- Understands that time-stamping precision matters in clinical systems — a 2-second discrepancy in an assessment submission timestamp is a regulatory event, not a rounding issue
Education and Experience
Education
- Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field
Required Experience
- 6–9 years of experience in software quality assurance for web applications
- 3+ years in a senior or lead QA capacity with ownership of test strategy and automation
- 2+ years providing QA leadership (test design guidance, standards enforcement, peer reviews) in a team environment3+ years working within regulated or validated software environments (GxP, FDA, HIPAA, or equivalent)
- Proven experience extending or improving an inherited test automation framework
- Hands-on Playwright experience (2+ years preferred)
- Experience with mobile app release processes including app store submission, per-client build configuration, and post-deployment validation
Preferred
- Experience in Life Sciences, Clinical Trials, Healthcare IT, or Medical Devices
- Experience with Storybook for component documentation and visual regression
- Familiarity with HashiCorp Vault or equivalent secrets management
- Familiarity with SonarQube or equivalent static analysis tooling
OTHER INFORMATION:
This job description captures the essential functions of this role as of April 2026 and reflects the actual technology stack and quality infrastructure of the iTakeControl platform. Management reserves the right to modify the description as the platform and team evolve.
What You Will Enjoy at Red Nucleus
- Competitive pay, incentives, retirement, and income security programs
- Comprehensive benefits and wellness programs focused on healthy lifestyles
- Generous paid time off, employee assistance programs and flexible work arrangements
- Performance driven environment including professional development and transfer opportunities
- People first culture fostering self expression, diversity, and a growth mindset
- Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
- Support of the community organizations you are passionate about
- Ongoing programs and events designed to bring our global team together
Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.
To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.
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