Quality Assurance Engineer

Role: Quality Assurance Engineer supporting GMP manufacturing of gene therapy products in clinical and commercial phases. Objectives: ensure compliance, quality, and inspection readiness in a fast-paced, highly regulated environment. Responsibilities: provide QA oversight for manufacturing operations, review and approve change controls, deviations, investigations, and CAPAs; support audits and inspections; collaborate with Engineering, Validation, and Operations to maintain compliance; author and review SOPs and quality documentation; oversee facility, equipment, and utility qualification activities; coordinate with suppliers and internal teams to uphold quality standards. Requirements: Bachelor’s in Engineering, Chemistry, Biochemistry, or related; minimum 5 years in biotech/pharma; strong knowledge of GMP, FDA, and global regulations; hands-on experience in validation, deviations, CAPA, change control; experience supporting regulatory audits; excellent communication and cross-functional collaboration skills. HighValue: gene therapy modalities, manufacturing environment, GMP compliance, regulatory audits, validation activities, cross-functional collaboration. WorkSetup: hybrid in Durham, NC (onsite at least 3 days/week).