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.

Leads coding QA specialists, oversees internal and vendor coding audits, develops SOPs and scoring methodologies, supports payer audits, monitors vendor performance, and turns audit findings into education and corrective actions. Requires deep HCC risk adjustment, ICD-10-CM, CMS, RADV, and clinical documentation expertise, along with team leadership and active AAPC or AHIMA credentials.

Manages site QA oversight of deviations and CAPAs, including triage, investigation review, approvals, training, and process improvement. Leads and develops QA staff, coordinates cross-functional quality systems work, tracks metrics, supports manufacturing and batch release timelines, and manages client communications. Collaborates with global QA, supports audits and regulatory inspections, and ensures compliance with GMP and worldwide biotechnology-product regulations.

Provides Quality oversight for laboratory, manufacturing, QC, and facilities operations at a cell and gene therapy manufacturing site. Responsibilities include shop-floor presence, batch and logbook review, GMP compliance, product disposition, deviation and CAPA approval, work-order and asset approvals, quality-system improvements, tech transfers, equipment qualification and validation, issue resolution, metrics, and regulatory inspection support. Requires onsite work and a flexible schedule, including alternate shifts.

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

Maintains the pharmaceutical Quality Management System across manufacturing operations. Responsibilities include validation and qualification review, deviation and OOS investigations, CAPA and change control oversight, batch record review and release, quality risk assessments, supplier quality, internal audits, regulatory inspection readiness, SOP management, and quality trend analysis. The role collaborates with manufacturing, engineering, supply chain, warehouse, and quality control teams to ensure GMP, client, and regulatory compliance.

Plan, conduct, and close independent GCP clinical audits across contracted countries; prepare and distribute audit reports; provide regulatory interpretation and consultation; review and track RCA/CAPA/EC plans; maintain eQMS; lead QA initiatives, training, and support inspections and corrective actions to ensure compliance with regulations, SOPs, and customer requirements.

Provides hands-on quality oversight for regulated pharmaceutical manufacturing, including batch record review and approval, GMP compliance, deviations, investigations, CAPA, data integrity, audits, inspections, quality metrics, and continuous improvement. Supports media, buffer, cell expansion, upstream, downstream, and aseptic filling operations while partnering with manufacturing teams to protect product quality and patient safety.

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.

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.

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.