Site Quality Director — Small Molecule Ramp-Up

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

Job summary

Novartis in Morrisville, NC seeks Site Quality Head to lead the Quality organization for a new Small Molecule site through ramp-up and commercialization. You will provide strategic leadership to ensure regulatory compliance, product quality, and operational excellence across manufacturing, QC, and supply chain, while building a high-performing team.

The role includes cgmp enforcement, Health Authority interactions, site leadership collaboration, and driving a culture of quality and continuous

Qualifications

• University degree in Pharmacy, Chemistry, Biotechnology, or related field.
• 10+ years pharma Quality/Manufacturing experience, including 5+ years with small molecules.
• Strong QA and QC background with cGMP knowledge.
• Experience leading regulatory inspections with Health Authorities.
• Proven people leadership with multiple direct reports.
• Experience in multinational pharmaceutical environments.

Responsibilities

• Lead the independent site Quality organization through ramp-up and commercialization.
• Establish and improve the Site Quality Management System (QMS) and governance.
• Ensure compliance with cGMP, regulatory requirements, and ISO standards; drive inspection readiness.
• Oversee Quality Risk Management, data integrity, and compliant records.
• Provide GxP oversight across manufacturing, QC, distribution, validation, and supplier quality.
• Lead Health Authority interactions and regulatory inspections; manage escalations.

Skills

Leadership

GxP knowledge

Regulatory experience

Quality Assurance

Quality Control

Cross-functional collaboration

Education

Pharmacy degree

Tools

QMS systems

Job description

Novartis in Morrisville, NC seeks Site Quality Head to lead the Quality organization for a new Small Molecule site through ramp-up and commercialization. You will provide strategic leadership to ensure regulatory compliance, product quality, and operational excellence across manufacturing, QC, and supply chain, while building a high-performing team.

The role includes cgmp enforcement, Health Authority interactions, site leadership collaboration, and driving a culture of quality and continuous