QA Delivery Leader - Life Sciences & Healthcare

We are looking for a seasoned Quality Engineering Delivery Lead to anchor our QE practice — a strategic life sciences client operating in the Clinical Data Management space. This role sits at the intersection of delivery ownership, client engagement, and quality governance, and requires someone who can translate complex technical quality requirements into structured, measurable delivery outcomes. The ideal candidate brings strong QE delivery credentials, a working understanding of regulated environments (21 CFR Part 11 / Part 820 preferred), and the ability to operate as a trusted advisor to both internal program leadership and client stakeholders.

KEY RESPONSIBILITIES Delivery Leadership & Governance • Own end-to-end QE delivery — planning, execution, and outcomes • Define and enforce testing standards, exit criteria, and release quality gates • Lead sprint-level and release-level QE ceremonies; represent QE in steering and status reviews • Drive risk identification and mitigation across functional, regression, integration, and UAT tracks • Maintain delivery dashboards and quality metrics for client-facing reporting Client Engagement & Stakeholder Management • Serve as the primary QE point of contact for client leadership and product stakeholders • Facilitate requirement walkthroughs, defect triage sessions, and retrospectives with client teams • Proactively surface delivery risks and quality signals to internal Delivery Head and client-side PMs • Build trust-based relationships with technical and business stakeholders Quality Strategy & Process Excellence • Design and implement a scalable QE framework aligned to product roadmap and data architecture • Define test strategy for data transformation, pipeline validation, and reporting layer testing (ETL/Medallion/BI) • Champion shift-left testing practices and integrate QE into CI/CD pipelines • Establish defect SLAs, triage workflows, and quality governance cadences Team Management & Mentoring • Lead a cross-functional QE team of testers, automation engineers, and QA analysts • Set individual goals, conduct performance reviews, and drive capability building • Identify skill gaps and define learning paths for team members Validation & Compliance (Life Sciences – Preferred) • Apply 21 CFR Part 11 validation principles to software testing in regulated clinical data environments • Support IQ/OQ/PQ validation activities, traceability matrices (RTM), and audit-ready documentation • Ensure test evidence packages meet regulatory and client compliance expectations • Familiarity with GAMP 5 guidelines and CSV (Computer System Validation) practices is a plus SKILLS & COMPETENCIES Core QE Competencies Delivery & Leadership Skills Test Strategy & Planning (Functional, Regression, Integration, E2E, UAT) Delivery ownership across multi-track, multi-sprint programs Test Automation (Selenium, Playwright, Cypress, API testing – Postman/RestAssured) Client stakeholder management and executive communication Data / ETL / Pipeline Testing (SQL, data validation, schema testing) Risk identification, mitigation planning, and escalation management CI/CD Integration (Jenkins, GitHub Actions, Azure DevOps) Resource planning, capacity management, team leadership Defect Lifecycle Management (JIRA, Zephyr, qTest) Metrics-driven delivery — dashboards, burn-down, quality KPIs Performance & Load Testing (JMeter, Gatling – preferred) Agile / SAFe delivery model experience QUALIFICATIONS Essential • 10–14 years of progressive QE/QA experience with a minimum of 3 years in a Delivery Lead or QE Manager role • Proven track record of managing end-to-end QE delivery for enterprise software programs • Strong hands-on background in test automation, API testing, and data validation • Experience working in Agile/Scrum delivery environments with direct client interaction • Excellent written and verbal communication — comfortable presenting to senior client stakeholders Preferred / Added Advantage • Domain experience in Life Sciences, Clinical Data Management, or Healthcare IT – Familiarity with EDC (Electronic Data Capture) systems – Understanding of clinical trial workflows — protocol design, data collection, study build • Working knowledge of 21 CFR Part 11 (Electronic Records/Signatures in regulated environments) – CSV validation lifecycle: IQ, OQ, PQ documentation – Validation Master Plan (VMP), Validation Summary Report (VSR), audit trail testing – Traceability matrix (RTM) for regulated test coverage • Exposure to GAMP 5 guidelines and Computer System Validation (CSV) practices • Experience testing data pipelines, ETL/ELT workflows, or BI/reporting platforms (Power BI, Sisense, Tableau) • Familiarity with cloud platforms — Azure, AWS, or GCP — especially in a data/analytics context CERTIFICATIONS (PREFERRED) ISTQB Certified Tester (Foundation / Advanced) Certified Software Quality Analyst (CSQA) PMP / Prince2 / SAFe (Delivery credential) AWS / Azure Fundamentals (Cloud awareness) WHAT YOU WILL BRING TO THE ROLE This role offers high visibility — you will operate as the QE face for a marquee life sciences account, collaborate with cross-functional delivery leadership, and have the opportunity to shape QE practice standards at an account level. If you thrive in structured delivery environments, enjoy client-facing ownership, and bring domain curiosity for life sciences and clinical data, this is the role for you.