Quality Systems & Compliance Leader

Biopharma Careers; United States; On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and 3

Generous time off

Job summary

Novartis is establishing a new Small Molecule manufacturing site in Morrisville, NC, and seeks a QA Compliance and Systems Head to build and lead the quality foundation from the ground up. You will oversee Quality Systems, Compliance, Audit Readiness, Data Integrity, Supplier Quality, and Validation, collaborating across Quality, Manufacturing, Engineering, and Regulatory functions.

You will drive a culture of compliance and continuous improvement, lead inspections, and support site

Qualifications

• Bachelor or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field; advanced degree preferred.
• 8–10 years of pharmaceutical manufacturing experience in roles such as Production, MKT, Quality, or Engineering.
• Experience in oral solid dose manufacturing preferred.
• Proven leadership in building talent, driving performance, and ensuring training compliance.
• Significant experience leading FDA inspections and regulatory interactions.
• Strong background in Quality Systems (deviations, CAPA, change control, data integrity, validation).
• Desirable: Lean/Operational Excellence qualifications or certifications.

Responsibilities

• Lead the site Quality Management System and ensure GMP compliance.
• Drive inspection readiness and lead audits by Health Authorities and customers.
• Oversee quality systems including deviations, CAPAs, change controls, data integrity, and validation.
• Partner with Manufacturing, QC, Validation, Engineering, and Regulatory teams to support site operations.
• Lead investigations of deviations and compliance issues and ensure timely resolutions.
• Oversee supplier quality, training governance, and risk management programs.

Job description

Novartis is establishing a new Small Molecule manufacturing site in Morrisville, NC, and seeks a QA Compliance and Systems Head to build and lead the quality foundation from the ground up. You will oversee Quality Systems, Compliance, Audit Readiness, Data Integrity, Supplier Quality, and Validation, collaborating across Quality, Manufacturing, Engineering, and Regulatory functions.

You will drive a culture of compliance and continuous improvement, lead inspections, and support site