Site Quality Leader – Small Molecule

Regulatory Jobs; Morrisville (NC); On-site; USD 168,000 - 312,000; Full time

Job summary

Novartis in Morrisville, North Carolina is seeking a senior Quality leader to head the site Quality organization, guiding ramp-up and commercialization efforts with strategic, compliant governance across QMS and site operations.

You will lead regulatory inspections, ensure data integrity, and build a high-performing team within the Site Leadership Team, driving safety and quality culture throughout the site.

Qualifications

• University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 10+ years of pharmaceutical Quality/Manufacturing experience, with at least 5 years in small molecules.
• Experience leading regulatory inspections and interactions with Health Authorities.

Responsibilities

• Lead the independent site Quality organization and provide strategic leadership.
• Establish and improve the site QMS and quality governance across site operations.
• Ensure compliance with cGMP and regulatory requirements, driving inspection readiness.
• Maintain data integrity and compliant quality records across all quality systems.
• Provide GxP oversight across Manufacturing, QA, distribution, validation, and facilities.
• Lead Health Authority interactions and respond to inspection observations.
• Recruit, develop, and retain a high-performing Quality organization within the site leadership team.
• Promote Safety and Quality culture and contribute to site strategy and excellence initiatives.

Skills

Quality leadership

Regulatory experience

GxP knowledge

Quality assurance

Cross-functional leadership

People management

Education

Pharmacy/chemistry/biotech degree

Job description

Novartis in Morrisville, North Carolina is seeking a senior Quality leader to head the site Quality organization, guiding ramp-up and commercialization efforts with strategic, compliant governance across QMS and site operations.

You will lead regulatory inspections, ensure data integrity, and build a high-performing team within the Site Leadership Team, driving safety and quality culture throughout the site.