Hybrid QA Engineer – GMP Gene Therapy

DTX Pharma, a Novartis Company; Durham (NC); Hybrid; USD 85,000 - 159,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Job summary

Novartis is seeking a Quality Assurance Engineer in Durham, NC for a hybrid role requiring onsite work at least 3 days a week. You will support clinical and commercial gene therapy manufacturing, ensure GMP compliance, and partner with Engineering, Validation, and Operations to uphold inspection readiness.

Ideal candidates have 5+ years in biotech/pharma, strong GMP knowledge, and proven experience with deviations, CAPAs, and change control processes.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biochemistry, or related field.
• Minimum 5 years of experience in 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

Data Integrity

GMP

Internal Quality Auditing

Managing Ambiguity

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

Quality Management Systems

Regulatory Compliance

SOP

SPC

Education

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

Job description

Novartis is seeking a Quality Assurance Engineer in Durham, NC for a hybrid role requiring onsite work at least 3 days a week. You will support clinical and commercial gene therapy manufacturing, ensure GMP compliance, and partner with Engineering, Validation, and Operations to uphold inspection readiness.

Ideal candidates have 5+ years in biotech/pharma, strong GMP knowledge, and proven experience with deviations, CAPAs, and change control processes.