Site Quality Director - Small Molecule Excellence

Novartis Group Companies; Morrisville (NC); On-site; USD 168,000 - 312,000; Full time

Benefits offered by this job

Health, life & disability benefits

401(k) with company match

Generous paid time off

Job summary

Novartis Group of Companies seeks a Site Quality Head in Morrisville, NC to lead the Quality organization at the new Small Molecule site during ramp-up and commercialization, ensuring regulatory compliance, product quality and operational excellence.

You will establish the Quality Management System, oversee GxP compliance, lead inspections with Health Authorities, develop a high-performing team, and collaborate with site leadership on strategic priorities.

Qualifications

• Advanced degree in a pharmaceutical/scientific field.
• Proven QA/QC and cGMP knowledge.
• Experience leading regulatory inspections.

Responsibilities

• Lead the independent site Quality organization through ramp-up and commercialization.
• Establish and improve the site QMS and governance across operations.
• Ensure cGMP, regulatory and ISO compliance and data integrity across QA/QC activities.
• Lead Health Authority interactions and regulatory inspections.
• Develop a high-performing Quality organization and coach leaders.

Skills

Leadership

Strategic thinking

Quality Assurance

Regulatory compliance

Quality Control

Quality Management

Education

University degree in Pharmacy, Chemistry, Biotechnology, or related scientific discipline

Job description

Novartis Group of Companies seeks a Site Quality Head in Morrisville, NC to lead the Quality organization at the new Small Molecule site during ramp-up and commercialization, ensuring regulatory compliance, product quality and operational excellence.

You will establish the Quality Management System, oversee GxP compliance, lead inspections with Health Authorities, develop a high-performing team, and collaborate with site leadership on strategic priorities.