Quality Systems & Compliance Leader – Associate Director

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

Job summary

Novartis is seeking a QA Compliance and Systems Head to build the quality foundation for a new Small Molecule site in Morrisville, NC. You will lead Quality Systems, Compliance, Audit Readiness, Data Integrity, and Supplier Quality while partnering across Quality, Manufacturing, Engineering and Regulatory to enable steady growth and transformation.

The role requires 8–10 years in pharmaceutical manufacturing with leadership experience, GMP expertise, and a track record of regulatory interactions

Qualifications

• Bachelor or Master degree in Life Sciences, Pharmacy, Chemistry, Biotechnology or related field; advanced degree preferred.
• 8–10 years in pharmaceutical manufacturing with leadership experience and regulatory exposure.
• Proven ability to lead FDA inspections and audit readiness activities.
• Strong experience with quality systems, deviations, CAPAs, change control, data integrity and validation.

Responsibilities

• Lead the site Quality Management System and ensure compliance with GMP and regulatory standards.
• Drive inspection readiness and lead preparation for audits and inspections.
• Oversee quality systems including deviations, CAPAs, change control, data integrity, and eCompliance.
• Partner with Manufacturing, QC, Validation, Engineering and Regulatory to support site operations.
• Lead investigations of deviations and compliance issues and ensure timely resolution.
• Oversee supplier quality, training governance, and risk management programs.

Skills

Leadership

Data integrity

Regulatory compliance

Audit readiness

Quality systems

Cross-functional collaboration

Risk management

Quality culture

Process improvement

Team development

Education

Bachelor's or Master's in Life Sciences/Pharma/Crench or related discipline

Tools

eCompliance

QMS (Quality Management System)

Validation processes

Job description

Novartis is seeking a QA Compliance and Systems Head to build the quality foundation for a new Small Molecule site in Morrisville, NC. You will lead Quality Systems, Compliance, Audit Readiness, Data Integrity, and Supplier Quality while partnering across Quality, Manufacturing, Engineering and Regulatory to enable steady growth and transformation.

The role requires 8–10 years in pharmaceutical manufacturing with leadership experience, GMP expertise, and a track record of regulatory interactions