QA Jobs in Cary, NC

Owns CAPA and nonconformance programs, maintains quality documentation and QMS processes, supports audits, analyzes quality data, and drives continuous improvement across regulated manufacturing operations. The role also supports contract manufacturers, validates analytical methods and quality standards, maintains BOM and database integrity, tracks KPIs, coordinates sample shipments, and resolves quality issues with cross-functional teams.

Leads the strategic vision, operations, financial health, and performance of the Quality organization. Oversees audits, inspections, quality metrics, procedures, regulatory compliance, client satisfaction, and stakeholder reporting. Represents Quality on leadership and board-level forums while supporting business development and key client relationships. Requires extensive drug development and clinical research experience, strong knowledge of global quality regulations, and executive leadership capabilities.

Supports clinical quality assurance through internal and client audits, quality system continuous improvement, SOP development, vendor quality management, regulatory compliance, and computer system validation. The role oversees quality activities for clinical trials, identifies and remediates trends, maintains electronic quality management systems, and collaborates cross-functionally on quality initiatives.

Lead site QA for GMP/GDP manufacturing and distribution, overseeing quality operations, deviations, CAPAs, inspections, secondary packaging, warehouse controls, and a QA team. Drive QMS improvements, regulatory compliance, risk-based decisions, and cross-functional stakeholder engagement to protect patient safety and product quality.

Lead Site Quality Assurance for a clinical manufacturing facility, overseeing CGMP compliance, quality operations, batch disposition, investigations, CAPA, change control, validation, regulatory inspections, supply chain quality, environmental monitoring, and data integrity. Build and mentor the local QA team, provide quality oversight for AAV and gene therapy manufacturing, support regulatory filings, and drive risk-based decisions and continuous improvement.

The QA Tester will be responsible for writing test cases, understanding testing methodologies, and documenting bugs. Familiarity with various operating systems and web technologies is essential.