Director, Site Quality & Compliance - Small Molecule

Novartis; United States; On-site; USD 168,000 - 312,000; Full time

Benefits offered by this job

Health benefits

Life and disability insurance

401(k) with company match

Paid time off

Job summary

Novartis seeks a Site Quality Head for our new Small Molecule site in Morrisville, North Carolina. You will lead the Quality organization through ramp-up and commercialization, ensuring regulatory compliance, product quality, and operational excellence across manufacturing operations.

You will establish the site Quality Management System, drive inspection readiness, build a high-performing team, and partner with site leadership on strategic priorities while maintaining cGMP and ISO compliance.

Qualifications

• Pharmacy/Chemistry/Biotechnology degree(s) required.
• 10+ years of pharmaceutical Quality and/or Manufacturing experience; at least 5 years with small molecules.
• Strong QA and QC background with knowledge of cGMP requirements.
• Proven experience leading regulatory inspections and interactions with Health Authorities.
• Demonstrated people leadership with multiple direct reports in a site leadership context.
• Experience in multinational pharmaceutical environments across sites and stakeholders.

Responsibilities

• Lead the independent site Quality organization through ramp-up and commercialization.
• Establish and maintain the site Quality Management System (QMS) and quality governance.
• Ensure compliance with cGMP, regulatory requirements, and ISO standards; drive inspection readiness and data integrity.

Skills

Quality Assurance

Quality Control

Regulatory inspections

Leadership

GxP oversight

Education

Pharmacy degree

Chemistry degree

Biotechnology degree

Job description

Novartis seeks a Site Quality Head for our new Small Molecule site in Morrisville, North Carolina. You will lead the Quality organization through ramp-up and commercialization, ensuring regulatory compliance, product quality, and operational excellence across manufacturing operations.

You will establish the site Quality Management System, drive inspection readiness, build a high-performing team, and partner with site leadership on strategic priorities while maintaining cGMP and ISO compliance.