QA Operations Leader - Quality, Compliance & Continuous Improvement

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

Benefits offered by this job

Health benefits

401(k) with company match

Disability benefits

Generous PTO

Job summary

Novartis is seeking a QA Operations Head for our new Morrisville site to lead quality operations and ensure the highest safety and regulatory standards. You will collaborate with Manufacturing, Quality Control and technical teams to drive excellence and shape the site’s quality culture.

As a visible site leader, you will empower high-performing teams, manage capacity and metrics, and champion continuous improvement aligned with the Novartis Technical Operations strategy.

Qualifications

• Bachelor or Master in Life Sciences, Pharmacy, Chemistry, Biotechnology or related discipline; advanced degree preferred.
• Minimum 8-10 years pharma experience including oral solid dosage manufacturing and QA/Engineering roles.
• Experience leading deviation investigations, CAPA, validation, and continuous improvement.

Responsibilities

• Provide quality leadership for product release, batch record review and disposition.
• Lead QA Operations oversight to ensure compliance across manufacturing activities.
• Drive investigations of deviations, out-of-spec results, and complaints with effective corrective actions.
• Support validation, technology transfer, and commissioning of new processes.
• Ensure inspection readiness and support internal and regulatory audits.

Skills

Quality Operations leadership

Regulatory compliance

Team leadership

Data analytics

Education

Bachelor/Master in Life Sciences or related

Job description

Novartis is seeking a QA Operations Head for our new Morrisville site to lead quality operations and ensure the highest safety and regulatory standards. You will collaborate with Manufacturing, Quality Control and technical teams to drive excellence and shape the site’s quality culture.

As a visible site leader, you will empower high-performing teams, manage capacity and metrics, and champion continuous improvement aligned with the Novartis Technical Operations strategy.