GMP Manufacturing Technical Support Manager

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC seeks a Manager of Manufacturing Technical Support to lead a high-performing team in GMP production operations onsite. You will provide technical oversight, resolve complex manufacturing challenges, and drive continuous improvement across safety, quality, and efficiency.

Responsibilities include investigating deviations, CAPA implementation, supporting change control, and maintaining documentation while ensuring FDA and GMP compliance in a fast-paced regulated environment.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, or related field.
• Experience leading technical teams in pharmaceutical/manufacturing environments.
• Strong knowledge of GMP regulations and FDA requirements.
• Experience conducting deviation investigations and CAPA implementations.

Responsibilities

• Lead and develop a high-performing Manufacturing Technical Support team for GMP production operations.
• Provide technical oversight to resolve complex manufacturing and process challenges.
• Drive continuous improvement for safety, quality, compliance, and efficiency.
• Collaborate with Manufacturing, Quality, Engineering, and other functions to meet production objectives.
• Investigate deviations and implement effective CAPA actions.
• Support change control and assess impact of process/equipment changes.
• Monitor process data for reliability and productivity improvements.
• Oversee GMP documentation, SOPs, and manufacturing records.
• Coach and develop team members and maintain inspection readiness.

Skills

Leadership

GMP knowledge

CAPA

Problem solving

Communication

Education

Bachelor's degree in Life Sciences/Engineering/Biotechnology

Job description

Novartis in Durham, NC seeks a Manager of Manufacturing Technical Support to lead a high-performing team in GMP production operations onsite. You will provide technical oversight, resolve complex manufacturing challenges, and drive continuous improvement across safety, quality, and efficiency.

Responsibilities include investigating deviations, CAPA implementation, supporting change control, and maintaining documentation while ensuring FDA and GMP compliance in a fast-paced regulated environment.