Hybrid QA Engineer — Gene Therapy GMP

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

Benefits offered by this job

Health benefits

401(k) plan with company match

Paid time off

Job summary

Novartis in Durham, NC seeks a Quality Assurance Engineer to ensure quality, compliance, and operational excellence in our GMP gene therapy manufacturing environment. You will collaborate with Engineering, Manufacturing, Validation and Operations to maintain inspection readiness and drive quality improvements.

The role requires a BS in a scientific field, 5+ years in biotech/pharma, and strong knowledge of GMP, regulatory audits, deviations, CAPAs, and change controls.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5+ years of experience in biotech/pharma.
• Strong knowledge of GMP and regulatory systems.

Responsibilities

• Provide QA support for clinical and commercial gene therapy manufacturing operations.
• Ensure compliance with GMP, FDA, and global regulatory requirements.
• Partner with Engineering, Validation, and Operations to maintain a compliant manufacturing environment.
• Support internal, customer, and regulatory audits and inspection readiness initiatives.
• Review and approve change controls, deviations, investigations, and CAPAs.
• Provide quality oversight for facility, utility, equipment, and process qualification activities.
• Collaborate with cross-functional teams to implement quality and compliance improvements.
• Review and approve project deliverables to ensure alignment with quality standards.
• Author, review, and approve SOPs and quality documentation supporting GMP operations.
• Work with suppliers and internal stakeholders to ensure ongoing quality and compliance standards.

Skills

Quality Assurance

GMP

Regulatory Compliance

CAPA & Deviation Management

Change Control

Cross-functional Collaboration

Technical Writing

Education

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

Job description

Novartis in Durham, NC seeks a Quality Assurance Engineer to ensure quality, compliance, and operational excellence in our GMP gene therapy manufacturing environment. You will collaborate with Engineering, Manufacturing, Validation and Operations to maintain inspection readiness and drive quality improvements.

The role requires a BS in a scientific field, 5+ years in biotech/pharma, and strong knowledge of GMP, regulatory audits, deviations, CAPAs, and change controls.