Director of Quality — Small Molecule Site

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); Vor Ort; USD 168.000 - 312.000; Vollzeit

Benefits dieser Stelle

Health benefits

401(k) with company match

Generous time off

Zusammenfassung

Novartis Innovative Technologies Inc in Morrisville, North Carolina, is seeking a Site Quality Head to lead the Quality organization at the new Small Molecule site. The role guides ramp-up and commercialization, ensuring regulatory compliance, product quality and operational excellence across manufacturing operations.

You will establish a comprehensive QMS, drive inspection readiness, oversee Health Authority interactions, and develop a high-performing team while partnering with site leadership

Qualifikationen

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

Aufgaben

• Lead the independent site Quality organization, providing strategic and operational Quality leadership through ramp-up and commercialization.
• Establish, maintain, and continuously improve the site Quality Management System (QMS).
• Ensure compliance with cGMP, regulatory requirements, Novartis Quality Standards, and ISO requirements; drive inspection readiness and governance.
• Provide GxP oversight across Manufacturing, QC, distribution, validation, and supplier quality.
• Lead Health Authority interactions and regulatory inspections; manage inspection observations and escalations.
• Recruit, develop, and retain a high-performing Quality organization and foster a strong quality culture.
• Serve as Site Head delegate and member of Site Leadership Team, supporting safety and strategic priorities.

Kenntnisse

Business Acumen

Change Management

Collaboration

Communication

Continuous Improvement

Financial Acumen

Leadership

People Management

Quality Assurance

Quality Compliance

Quality Management

Quality Management Systems

Risk-Based Decision Making

Risk Management

Stakeholder Management

Storytelling

Strategic Thinking

Ausbildung

Pharmacy/Related scientific discipline

Jobbeschreibung

Novartis Innovative Technologies Inc in Morrisville, North Carolina, is seeking a Site Quality Head to lead the Quality organization at the new Small Molecule site. The role guides ramp-up and commercialization, ensuring regulatory compliance, product quality and operational excellence across manufacturing operations.

You will establish a comprehensive QMS, drive inspection readiness, oversee Health Authority interactions, and develop a high-performing team while partnering with site leadership