Qa Lead

Clymb Clinical Research; Thiruvananthapuram; Hybrid; INR 2,200,000 - 4,000,000; Full time

Job summary

Clymb Clinical Research in Trivandrum is offering a hybrid, full-time QA Lead position for an experienced QA professional. You will drive QA processes, ensure traceability, and support audits to ensure compliant SaaS releases.

The role focuses on leading the QA team and aligning QA practices with SDLC and regulatory requirements. Ideal candidates have 8+ years in software QA, strong QA governance, risk management, and hands-on testing, automation, and collaboration across product, DevOps, and

Qualifications

• 8+ years of Software QA experience with a QA Lead or senior role.
• Strong understanding of SaaS product development and SDLC processes.
• Experience with vendor audits, customer audits and ISO audits.
• Knowledge of 21 CFR Part 11, HIPAA, GDPR, ISO 27001 and data privacy.
• Experience generating validation and test packages.
• Experience with SOPs, CAPA, risk management and audit readiness.
• Excellent documentation and stakeholder management skills.
• Ability to mentor and guide a QA team.

Responsibilities

• Lead QA activities across the SaaS product lifecycle from requirements to release.
• Define and implement QA strategies, processes, tests, and quality metrics.
• Lead functional, integration, regression, system and release testing.
• Ensure end-to-end traceability of requirements, tests, defects and releases.
• Support audits and maintain audit evidence and compliance records.
• Identify gaps, drive CAPA, and continuous improvement.
• Collaborate with Development, Product, DevOps, Security and Projects.
• Review test plans, cases, automation coverage, and release readiness.

Skills

QA leadership

SaaS product development

SDLC knowledge

Audit readiness

Test planning

Automation testing

CI/CD

Documentation

Tools

Jira

Xray

Playwright/Selenium

Git

CI/CD pipelines

Job description

QA Lead

Experience: 8+ Years | Location: Trivandrum / Hybrid | Employment Type: Full-time

Role Overview

We are looking for an experienced QA Lead with 8+ years of experience in software quality assurance and product development. The ideal candidate should have strong experience in SaaS product development, QA processes, compliance, audits, and quality management. The candidate should be capable of independently driving QA processes, supporting audits, identifying process gaps, and guiding the QA team to ensure high-quality, traceable, and compliant product releases.

Key Responsibilities

• Lead QA activities across the complete SaaS product lifecycle, from requirements and risk assessment through test execution, release validation, and production release.
• Define and implement QA strategies, processes, standards, test plans, and quality metrics.
• Lead functional, integration, regression, system, and release testing activities.
• Ensure end-to-end traceability between requirements, development, test evidence, defects, approvals, and releases.
• Support and participate in 21 CFR Part 11, HIPAA, GDPR, ISO 27001, information security, vendor, and customer audits.
• Prepare and maintain audit evidence, SOPs, test documentation, quality records, and compliance documentation.
• Identify process gaps and drive CAPA, risk mitigation, and continuous improvement.
• Support audit readiness and ensure timely closure of audit observations and findings.
• Work closely with Development, Product, DevOps, Security, and Project teams to ensure product quality and compliance.
• Review test plans, test cases, automation coverage, defects, test evidence, traceability, and release readiness.
• Establish and continuously improve QA processes aligned with the organization’s SDLC and SaaS development practices.
• Mentor and guide QA team members and promote strong quality practices across the organization.
• Ensure production releases meet defined quality, compliance, validation, traceability, and customer expectations.

Required Skills & Experience

• 8+ years of experience in Software Quality Assurance, with experience in a QA Lead or similar senior role.
• Strong understanding of SaaS product development and SDLC processes.
• Experience with vendor audits, customer audits, ISO audits, and information security audits.
• Good understanding of 21 CFR Part 11, HIPAA, GDPR, ISO 27001, data privacy, information security, and compliance requirements.
• Experience generating validation and test packages.
• Experience with quality processes including SOPs, CAPA, risk management, change management, and audit readiness.
• Strong experience in test planning, execution, defect management, and release validation.
• Good understanding of test automation and CI/CD practices.
• Experience working in Agile/Scrum product development environments.
• Strong documentation, analytical, communication, and stakeholder management skills.
• Ability to independently drive QA processes and effectively guide and mentor a QA team.

Preferred Skills

• Experience working in healthcare, clinical, life sciences, or other regulated software environments.
• Experience with Jira, Xray, Playwright/Selenium, Git, and CI/CD pipelines.
• Experience preparing audit evidence and managing audit observations through closure.
• Knowledge of software validation and compliance practices.
• Relevant certifications in QA, ISO 27001, information security, privacy, or compliance would be an advantage.