GMP Manufacturing Technical Support Manager

Novartis Group Companies; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis Group Companies in Durham, NC, is seeking a Manager, Manufacturing Technical Support, to lead a GMP-focused team onsite and drive technical excellence across manufacturing operations.

You will mentor and develop staff, resolve complex process challenges, and partner with Quality, Engineering, and Manufacturing to sustain safety, quality, and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, or related scientific discipline.
• Proven leadership experience managing technical teams and developing high-performing employees.
• Strong knowledge of GMP regulations and FDA requirements within a manufacturing setting.
• Experience leading deviation investigations, root cause analysis, and CAPA implementation.
• Experience collaborating across Quality, Manufacturing, Engineering, and Supply Chain functions.

Responsibilities

• Lead and develop a high-performing Manufacturing Technical Support team supporting GMP production operations.
• Provide technical oversight and troubleshooting to resolve complex manufacturing and process challenges.
• Drive continuous improvement initiatives to enhance safety, quality, compliance, and operational efficiency.
• Partner with Manufacturing, Quality, Engineering, and other functions to achieve production objectives.
• Ensure timely investigation of deviations and implementation of effective CAPA activities.
• Support change control activities and assess manufacturing impact of process or equipment changes.
• Monitor process performance data and identify opportunities for reliability and productivity improvements.
• Oversee creation, review, and approval of GMP documentation, SOPs, and manufacturing records.
• Build team capabilities through coaching, training, performance management, and employee development.
• Maintain inspection readiness and ensure compliance with FDA, GMP, and company quality standards.

Skills

Leadership

GMP compliance

Root cause analysis

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Life Sciences, Engineering, Biotechnology, or related scientific discipline

Job description

Novartis Group Companies in Durham, NC, is seeking a Manager, Manufacturing Technical Support, to lead a GMP-focused team onsite and drive technical excellence across manufacturing operations.

You will mentor and develop staff, resolve complex process challenges, and partner with Quality, Engineering, and Manufacturing to sustain safety, quality, and regulatory compliance in a fast-paced environment.