Senior Quality Systems & Compliance Leader (Assoc Dir)

NCBiotech; Durham (NC); On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Performance-based incentive

Equity awards potential

Comprehensive benefits package (health

401(k) with company match and vacation

Job summary

Novartis is seeking a QA Compliance and Systems Head for a new Morrisville, NC site to shape quality systems, compliance programs, and inspection readiness. Lead deviations, CAPA, data integrity, and supplier quality while partnering across Quality, Manufacturing, Engineering, and Regulatory.

Responsibilities include building a high-performing QA team, advancing digital enablement, and driving continuous improvement and risk management within a highly regulated manufacturing environment.

Qualifications

• Bachelor's or Master in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field; advanced degree preferred.
• 8–10 years of pharmaceutical manufacturing experience, including leadership roles.
• Proven track record leading FDA inspections and audit readiness.
• Strong leadership, training development, and collaboration across Quality, Manufacturing, Regulatory.

Responsibilities

• Lead the site Quality Management System and ensure GMP compliance.
• Drive inspection readiness and lead audits and Health Authority inspections.
• Oversee quality systems including deviations, CAPA, change control, data integrity.
• Partner with Manufacturing, QC, Validation, Technical Operations, Engineering, Regulatory.
• Lead investigations of deviations and compliance issues.
• Promote a culture of accountability, continuous improvement, and risk management.

Skills

Business Acumen

Collaboration

Data Integrity

Decision Making

Leadership

Risk Management

Strategic Planning

Education

Bachelor's or Master’s Degree in Life Sciences / Pharmacy / Chemistry / Biotechnology or related field

Advanced degree preferred

Job description

Novartis is seeking a QA Compliance and Systems Head for a new Morrisville, NC site to shape quality systems, compliance programs, and inspection readiness. Lead deviations, CAPA, data integrity, and supplier quality while partnering across Quality, Manufacturing, Engineering, and Regulatory.

Responsibilities include building a high-performing QA team, advancing digital enablement, and driving continuous improvement and risk management within a highly regulated manufacturing environment.