Hybrid QA Engineer: GMP Compliance for Gene Therapy

Novartis Group Companies; Durham (NC); Hybrid; USD 85,000 - 159,000; Full time

Job summary

Novartis Group of Companies is seeking a Quality Assurance Engineer in Durham, NC, for a hybrid role onsite at least 3 days weekly. You will ensure GMP compliance, support gene therapy manufacturing, and drive inspection readiness across Engineering, Manufacturing, Validation and Operations.

You will review change controls, deviations and CAPAs, author SOPs, and oversee QC activities. Strong writing, communication and cross-functional skills are essential for success in this highly regulated

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biochemistry or related field.
• Minimum 5 years in biotechnology/pharmaceutical industry.
• Strong knowledge of GMP and quality systems.
• Experience supporting regulatory inspections and audits.
• Hands-on commissioning, qualification and validation activities.

Responsibilities

• Provide QA support for gene therapy manufacturing operations.
• Ensure GMP/regulatory compliance across manufacturing activities.
• Collaborate with Engineering, Validation and Operations to maintain compliant environment.
• Support internal, customer and regulatory audits and inspections.

Skills

Quality assurance

Regulatory compliance

Documentation

Cross-functional collaboration

Audits & inspections

Education

Bachelor's degree in Engineering, Chemistry, Biochemistry, or related

Job description

Novartis Group of Companies is seeking a Quality Assurance Engineer in Durham, NC, for a hybrid role onsite at least 3 days weekly. You will ensure GMP compliance, support gene therapy manufacturing, and drive inspection readiness across Engineering, Manufacturing, Validation and Operations.

You will review change controls, deviations and CAPAs, author SOPs, and oversee QC activities. Strong writing, communication and cross-functional skills are essential for success in this highly regulated