Hybrid QA Engineer for GMP Gene Therapy

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; Hybrid; USD 85,000 - 140,000; Full time

Job summary

Novartis is seeking a Quality Assurance Engineer in Durham, NC, to join a GMP manufacturing environment focused on gene therapy. Hybrid work requires onsite presence at least 3 days per week, with emphasis on inspection readiness and quality improvements across engineering, validation, and operations teams.

The role requires a Bachelor’s degree in a scientific field and 5+ years in biotech/pharma, with strong GMP knowledge and experience in audits, deviations, CAPAs, and SOPs.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum 5 years of experience in the biotechnology or pharmaceutical industry.
• Strong knowledge of current Good Manufacturing Practice regulations and quality systems.
• Experience supporting regulatory inspections and audits within a regulated manufacturing environment.
• Hands-on experience with commissioning, qualification, and validation activities.
• Experience managing deviations, corrective and preventive actions, and change control processes.
• Experience authoring, reviewing, or approving standard operating procedures and quality documentation.
• Strong communication, technical writing, problem-solving, and cross-functional collaboration skills.

Responsibilities

• Provide QA support for clinical and commercial gene therapy manufacturing operations.
• Ensure compliance with GMP, FDA, and global regulatory requirements across manufacturing activities.
• 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

Collaboration

Communication

Data Integrity

GMP

Internal Quality Auditing

Managing Ambiguity

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

QMS

Regulatory Compliance

SOP

SPC

Education

Bachelor’s degree in Engineering, Chemistry, Biochemistry, or a related scientific discipline

Job description

Novartis is seeking a Quality Assurance Engineer in Durham, NC, to join a GMP manufacturing environment focused on gene therapy. Hybrid work requires onsite presence at least 3 days per week, with emphasis on inspection readiness and quality improvements across engineering, validation, and operations teams.

The role requires a Bachelor’s degree in a scientific field and 5+ years in biotech/pharma, with strong GMP knowledge and experience in audits, deviations, CAPAs, and SOPs.