Red Nucleus is hiring a QA Lead (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 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
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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
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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
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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 team's 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
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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
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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 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 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
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Regulatory and Compliance Knowledge
- Experience working in GxP-regulated, FDA-regulated, or HIPAA-compliant software environments
- Practical knowledge of IQ/OQ/PQ validation lifecycle and preparation of validation documentation packages
- ALCOA+ principles applied to test evidence, audit trail requirements, and clinical data records
- FDA 21 CFR Part 11 requirements for electronic records and signatures
- Understands clinical data integrity requirements including time-stamping precision, audit trail completeness, and the regulatory weight of data discrepancies in a live study environment
Understanding of LMS standards like SCORM, xAPI would be an added advantage.
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Education and Experience
Education
Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field
Required Experience
- 8+ years of experience in software quality assurance for web applications
- 4+ years in a lead or senior QA capacity with ownership of test strategy and automation
- 1–2 years direct people management or team lead responsibility — including hiring, onboarding, and performance input — for at least 1–2 QA engineers
- 3+ 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); or strong Cypress/Selenium background with demonstrated ability to adopt Playwright
- Experience with mobile app release processes including app store submission, per-client build configuration, and post-deployment validation
Familiar with responsive design testing, WCAG accessibility standards, and core UX/design principles; able to evaluate deliverables for usability, consistency, and end-user experience quality across devices and screen sizes
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Preferred
- Experience in Life Sciences, Clinical Trials, Healthcare IT, or Medical Devices
- Familiarity with HashiCorp Vault or equivalent secrets management
- Storybook for component documentation and visual regression
- SonarQube static analysis QA input on coverage thresholds and rule configuration is expected
AI-assisted testing tools — familiarity with tools such as Mabl, Testim, or Applitools; or experience using AI coding assistants (GitHub Copilot, etc.) for test generation and coverage analysis
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OTHER INFORMATION:
This job description captures the essential functions of this role as of May 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
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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.
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