Lead, GMP Manufacturing Technical Support

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

Benefits offered by this job

Performance-based incentive

Equity awards eligibility

Comprehensive benefits package

Job summary

Novartis in Durham, NC, seeks a Manager of Manufacturing Technical Support to lead a GMP-focused team. You will oversee technical troubleshooting, CAPA programs, and deviation investigations while driving safety, quality, and process improvements in a fast-paced regulated environment.

You will partner with Manufacturing, Quality, Engineering, and Supply Chain to achieve production goals, ensuring inspection readiness and regulatory compliance.

Qualifications

• Demonstrated leadership experience managing technical teams in regulated manufacturing.
• GMP regulations and FDA requirements in a manufacturing setting.
• Experience leading deviation investigations and root cause analysis with CAPA closure.
• Ability to collaborate across Quality, Manufacturing, Engineering, and Supply Chain.
• Strong communication, problem-solving, and organizational skills in a fast-paced environment.

Responsibilities

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

Skills

Leadership

GMP knowledge

CAPA implementation

Cross-functional collaboration

Communication

Education

Bachelor's degree in Life Sciences or related

Job description

Novartis in Durham, NC, seeks a Manager of Manufacturing Technical Support to lead a GMP-focused team. You will oversee technical troubleshooting, CAPA programs, and deviation investigations while driving safety, quality, and process improvements in a fast-paced regulated environment.

You will partner with Manufacturing, Quality, Engineering, and Supply Chain to achieve production goals, ensuring inspection readiness and regulatory compliance.