Senior GMP Quality Assurance Specialist (Manufacturing)

Novartis AG; Durham (NC); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis AG in Durham, NC is seeking a Manufacturing Quality Assurance Specialist to partner with manufacturing teams on the shop floor, ensuring production meets quality and regulatory standards. The role emphasizes real-time oversight, batch record review, and continuous improvement within a GMP environment.

The successful candidate will bring a BS in a scientific discipline, at least five years in GMP manufacturing, and strong knowledge of CFR, FDA, and EU regulations.

Qualifications

• Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline.
• Minimum of five years of experience working in a regulated GMP manufacturing environment.
• Strong working knowledge and application of CFR, FDA, and EU regulatory requirements.
• Proven experience supporting or participating in FDA and EU regulatory inspections and audits.
• Hands-on experience reviewing, authoring, and approving quality procedures and standard operating documents.
• Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure.
• Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward.
• Excellent written and verbal communication skills with the ability to collaborate effectively across functions.

Responsibilities

• Provide proactive quality oversight through shop floor presence, walkthroughs, and real-time manufacturing support.
• Review and approve master and executed batch records to ensure compliant clinical and commercial production.
• Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements.
• Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations.
• Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation.
• Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance.
• Support internal and external audits, inspections, and regulatory readiness activities.
• Provide quality expertise in manufacturing batch record design, review, and continuous improvement.
• Analyze quality metrics, identify trends, and communicate actionable insights to management.
• Lead or contribute to continuous improvement and quality system enhancement projects.

Skills

Quality oversight

GMP compliance

Data analysis

Deviations & CAPA

Education

Bachelor of Science in microbiology, chemistry, biochemistry, or related

Job description

Novartis AG in Durham, NC is seeking a Manufacturing Quality Assurance Specialist to partner with manufacturing teams on the shop floor, ensuring production meets quality and regulatory standards. The role emphasizes real-time oversight, batch record review, and continuous improvement within a GMP environment.

The successful candidate will bring a BS in a scientific discipline, at least five years in GMP manufacturing, and strong knowledge of CFR, FDA, and EU regulations.