QA Lead – Batch Disposition & Compliance

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition, ensuring GMP compliance and timely product release across clinical and commercial programs. This onsite role collaborates with Manufacturing and Quality teams in a fast-paced environment.

You will drive investigations, deviations, CAPAs, and Change Controls, review and approve controlled documents, and support regulatory inspections.

Qualifications

• Bachelor’s degree in biology, engineering, or a related scientific discipline.
• Minimum 5 years of experience in Batch Disposition and/or Quality Assurance within a GMP-regulated environment.
• Proven experience performing batch record review and supporting product release activities.
• Strong knowledge of GMP regulations and quality systems within the biopharmaceutical industry.
• Experience supporting manufacturing operations including cell culture, purification, or aseptic fill-finish processes.
• Demonstrated experience managing deviations, CAPAs, and Change Controls.
• Experience supporting regulatory inspections and health authority audits, including FDA inspections.
• Strong attention to detail, sound quality judgment, and ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Lead batch record review and disposition activities to support timely product release.
• Make quality-based disposition decisions for raw materials, consumables, intermediates, and finished product.
• Partner with Manufacturing and Quality teams to ensure GMP compliance throughout production operations.
• Support release of clinical and commercial products in accordance with regulatory requirements.
• Issue and manage batch records and associated manufacturing documentation.
• Review, author, and approve SOPs, work instructions, specifications, and other controlled documents.
• Drive investigations, deviations, CAPAs, and Change Controls impacting product quality and release.
• Support internal audits, regulatory inspections, and ongoing FDA inspection readiness activities.
• Monitor quality metrics and contribute to Quality Management Review reporting and site performance initiatives.
• Identify and implement continuous improvement opportunities that strengthen Quality Systems and operational effectiveness.

Skills

Quality Assurance

GMP

Data Integrity

Regulatory Compliance

Quality Management Systems

Standard Operating Procedure

Internal Quality Auditing

Collaboration

Communication

Operational Excellence

Quality Control

Statistical Process Control

Education

Bachelor’s degree in Biology, Engineering, Microbiology, Chemistry, Biochemistry

Job description

Novartis in Durham, NC is seeking a Quality Assurance Specialist, Batch Disposition to lead batch review and disposition, ensuring GMP compliance and timely product release across clinical and commercial programs. This onsite role collaborates with Manufacturing and Quality teams in a fast-paced environment.

You will drive investigations, deviations, CAPAs, and Change Controls, review and approve controlled documents, and support regulatory inspections.