QA Compliance Specialist

Job description

Job Description Summary In this role, you’ll be at the heart of ensuring quality, compliance, and trust as we advance innovative gene therapies for patients worldwide. As a QA Compliance Specialist, your expertise will directly shape how quality systems are applied, strengthened, and continuously improved across the site—supporting both development and commercialization. You’ll partner closely with cross-functional teams, influence critical decisions, and serve as a trusted voice on compliance, helping turn complex challenges into clear, risk-based solutions that protect patients and products alike. Location: - This position will be located in Durham, NC and will be a Hybrid role. - Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: - Establish and maintain site quality system processes supporting development and commercialization of advanced gene therapy medicines - Drive consistent execution of change control and non-conformance programs aligned with global quality system standards - Lead investigations, root cause analysis, and timely corrective and preventive actions using a risk-based ap...