QA Jobs in Durham, NC

The Executive Director provides leadership for Quality Assurance and Regulatory Compliance in Clinical Pharmacology Services, ensuring a quality management system aligned with regulations and business strategy. Responsibilities include overseeing QA audits, compliance risks, and employee management, while fostering a culture of quality and operational excellence.

Lead product quality across NPI and lifecycle: establish quality plans, own E2E scorecards and reporting, monitor production/field metrics, drive corrective/preventive actions, support supplier audits and manufacturing readiness, maintain quality systems and documentation, and partner cross-functionally to translate quality data into executive decisions.

Analyze requirements and functional/technical specs to develop test conditions, cases, and automated scripts. Execute manual and automated tests (web, GUI, client/server, database), validate results via SQL and UNIX, report and track defects, review test artifacts, and ensure testing adherence to project schedules and standards.

Lead quality oversight of external aseptic CMOs for sterile fill-finish, ensuring cGMP compliance, managing deviations/CAPAs, reviewing batch records and validations, supporting QP release, conducting audits, driving continuous improvement, and collaborating across Manufacturing, Supply Chain, Regulatory, and Technical Operations.

Own testing strategy and execution for new features, design and maintain manual, exploratory, regression, and end-to-end Playwright automation, perform REST API testing, integrate tests into GitLab CI/CD, review requirements, perform root-cause analysis, mentor junior QA, and leverage AI-assisted testing to improve coverage and productivity.

Plan, conduct, and report independent GxP audits across countries; evaluate findings, consult on regulations, manage quality issues (RCA/CAPA), maintain eQMS records, support inspections, train staff, and lead QA improvement projects.

Assist in ensuring quality in mobile and web applications as a QA Analyst by creating test plans, executing tests, and documenting issues.

The QA Specialist II ensures compliance through reviewing and approving GMP data, method qualifications, validations, and laboratory investigations in biopharmaceutical development.

Lead QA analyst responsible for test strategy, automation, integration and end-to-end testing of web and API-based enterprise applications. Mentor junior analysts, estimate and manage risks, collaborate with stakeholders, and drive quality across the software lifecycle.

Lead and manage regional/global QA programs, audits, SOP authoring, compliance oversight, corrective action review, trend analysis, and cross-functional quality improvement initiatives. Provide regulatory guidance, train stakeholders, oversee QA metrics and customer audits, and manage teams and QA activities to ensure GxP compliance and process quality.

The QA Test Lead oversees the testing process, analyzes business requirements, develops test conditions, and manages test case execution and reporting for software quality assurance.

The Sr Quality Assurance Engineer ensures compliance with quality standards, implements quality management systems, conducts audits, and resolves supplier issues, promoting continuous improvement.