Site Quality Director, Small Molecule Ramp-Up

Novartis AG; Morristown (VT); Vor Ort; USD 168.000 - 312.000; Vollzeit

Benefits dieser Stelle

Health benefits

401(k) with company match

Equity awards eligibility

Generous paid time off

Zusammenfassung

Novartis Morrisville is seeking a Site Quality Head to lead the Quality organization for the new Small Molecule site in Morrisville, North Carolina. You will guide ramp-up and commercialization, ensuring regulatory compliance and operational excellence across manufacturing operations.

You will build a high-performing Quality organization, drive continuous improvement, and partner with site leadership to support strategic priorities and a culture of quality.

Qualifikationen

• Pharmacy, Chemistry, Biotechnology or related science degree required.
• 10+ years in pharmaceutical QA/manufacturing; minimum 5 years in small molecules.
• Strong QA/QC background with knowledge of cGMP.
• Experience leading regulatory inspections with Health Authorities.
• Proven leadership with multiple direct reports.
• Experience in multinational pharmaceutical environments.

Aufgaben

• Lead the site Quality organization across ramp-up and commercialization.
• Establish and improve the site QMS and quality governance.
• Ensure compliance with cGMP, regulatory and ISO standards.
• Drive data integrity, records, and quality issue management.
• Oversee QA across manufacturing, QC, distribution, and validation.
• Develop, mentor, and retain a high-performing quality team.

Kenntnisse

Quality Assurance

Quality Control

Regulatory Inspections

Leadership

People Management

Quality Management Systems (QMS)

cGMP Compliance

Cross-functional Collaboration

Ausbildung

Pharmacy degree

Chemistry or Biotechnology degree

Jobbeschreibung

Novartis Morrisville is seeking a Site Quality Head to lead the Quality organization for the new Small Molecule site in Morrisville, North Carolina. You will guide ramp-up and commercialization, ensuring regulatory compliance and operational excellence across manufacturing operations.

You will build a high-performing Quality organization, drive continuous improvement, and partner with site leadership to support strategic priorities and a culture of quality.