QA testing
QA and Validation Lead
Location : Remote (EST time)
Duration: Long term
Pharmaceutical / Life Sciences Platforms-MUST
Position SummaryWe are seeking an experienced QA Lead / Test Lead to drive quality assurance and validation activities across critical systems in a regulated life sciences environment. This role will lead testing strategy, execution, and compliance for GxP systems such as CRM, MLR platforms, data platforms, and enterprise applications. The ideal candidate brings deep expertise in validation, strong leadership capabilities, and a thorough understanding of regulatory requirements (FDA, GxP, 21 CFR Part 11).
Key Responsibilities
QA Leadership & Strategy
Define and lead QA and testing strategy across projects and platforms
Establish testing standards, methodologies, and best practices
Manage end-to-end testing lifecycle (SIT, UAT, regression, validation testing)
Act as the primary QA point of contact for stakeholders and leadership
Validation & Compliance (CSV)
Lead Computer System Validation (CSV) activities in alignment with GxP requirements
Author and review validation deliverables (e.g., Validation Plan, URS, FS/DS, IQ/OQ/PQ, Traceability Matrix)
Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+)
Support audit readiness and participate in internal/external audits
Test Management & Execution
Develop detailed test plans, test cases, and test scripts
Oversee defect management lifecycle, including tracking, triage, and resolution
Coordinate SIT/UAT cycles with business stakeholders and SMEs
Ensure appropriate test coverage, risk-based testing, and documentation
Team Leadership & Collaboration
Lead and mentor QA analysts and offshore/onshore testing teams
Collaborate with Business Analysts, Product Owners, IT, and vendors
Provide status reporting, risk assessment, and executive-level updates
Drive continuous improvement across QA processes and tools
Supported Systems & Platforms
CRM: Veeva CRM, Salesforce
MLR/PRC: Veeva PromoMats, AgileLoft
Data & Analytics: Snowflake, Databricks, Power BI
LMS: ComplianceWire or similar
Clinical / Regulatory / Quality systems as applicable
Required Qualifications
Bachelor’s degree in Life Sciences, Computer Science, or related field
7+ years of QA/testing experience, including 2–3+ years in a lead role
Strong experience with Computer System Validation (CSV) in GxP environments
Deep knowledge of FDA regulations, 21 CFR Part 11, and data integrity principles
Proven experience in test management tools (e.g., Jira, ALM, Azure DevOps)
Experience leading cross-functional and distributed QA teams
Strong understanding of SDLC methodologies (Waterfall, Agile, Hybrid)
Preferred Qualifications
Experience with Veeva Vault, AgileLoft, or other life sciences platforms
Familiarity with automation testing tools (e.g., Selenium, Test automation frameworks)
Experience with cloud platforms (AWS, Azure) and data validation
Knowledge of risk-based validation approaches (CSA – Computer Software Assurance)
PMP, ISTQB, or related QA/validation certifications
Key Competencies
Regulatory and compliance expertise
Leadership and team management
Strong analytical and problem-solving skills
Attention to detail and documentation rigor
Excellent stakeholder communication and influencing skills
To apply for this job email your details to harman@hmgamerica.com