Quality Systems & Compliance Leader (Assoc Dir)

Novartis Group Companies; Durham (NC); On-site; USD 138,600 - 257,400; Full time

Job summary

Novartis Group Companies in Morrisville, NC, is seeking a QA Compliance and Systems Head to shape the quality foundation for the new Small Molecule manufacturing site. You will oversee quality systems, compliance programs, and inspection readiness while partnering across Quality, Manufacturing, Engineering and Regulatory functions.

As a senior site leader, you will drive a culture of accountability, continuous improvement, and risk management, lead investigations, and advance digital enablement

Qualifications

• Bachelor or Master in Life Sciences, Pharmacy, Chemistry, Biotechnology or related field.
• 8–10 years of pharmaceutical manufacturing experience.
• Experience leading FDA inspections and regulatory interactions.
• Strong leadership and cross-functional collaboration.

Responsibilities

• Lead the site Quality Management System and ensure GMP compliance.
• Drive inspection readiness and prepare for audits.
• Oversee quality systems including deviations, CAPAs, change controls, data integrity, and validation.
• Partner with Manufacturing, QC, Validation, Technical Operations, Engineering, and Regulatory teams.
• Lead investigations of deviations and compliance issues.
• Oversee supplier quality and training governance.

Skills

Leadership

Data Integrity

Risk Management

Continuous Improvement

Collaboration

Strategic Planning

Decision Making

Education

Bachelor or Master in Life Sciences/Pharmacy/Chemistry/Biotechnology

Advanced degree preferred

Tools

eCompliance

Job description

Novartis Group Companies in Morrisville, NC, is seeking a QA Compliance and Systems Head to shape the quality foundation for the new Small Molecule manufacturing site. You will oversee quality systems, compliance programs, and inspection readiness while partnering across Quality, Manufacturing, Engineering and Regulatory functions.

As a senior site leader, you will drive a culture of accountability, continuous improvement, and risk management, lead investigations, and advance digital enablement