GMP Manufacturing Tech Support Leader

Novartis; 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 GMP-focused team, drive technical excellence, and ensure safe, efficient production in a regulated environment.

The role requires strong leadership, deep GMP/FDA knowledge, and experience in deviation investigations and CAPA. Onsite, onsite collaboration across Quality, Engineering, and Supply Chain enables reliable manufacturing performance.

Qualifications

• Bachelor's degree required in Life Sciences, Engineering, Biotechnology or related.
• Minimum 7 years of experience in pharmaceutical, biopharmaceutical, biotechnology, or chemical manufacturing environments.
• Demonstrated 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.
• Proven ability to support manufacturing operations and resolve complex technical challenges.

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 knowledge

Regulatory compliance

Problem solving

Cross-functional collaboration

Communication

Education

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

Job description

Novartis in Durham, NC, seeks a Manager of Manufacturing Technical Support to lead a GMP-focused team, drive technical excellence, and ensure safe, efficient production in a regulated environment.

The role requires strong leadership, deep GMP/FDA knowledge, and experience in deviation investigations and CAPA. Onsite, onsite collaboration across Quality, Engineering, and Supply Chain enables reliable manufacturing performance.