QA Compliance Team Lead - Quality Systems & Audits

Novartis; Morris Plains (NJ); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and匹

Job summary

Novartis in Morris Plains, NJ, is seeking a Quality Team Leader QA Compliance to lead a high-performing team and uphold cGMP quality across operations. You will drive continuous improvement, support regulatory inspections, and partner with functions to ensure product quality and data integrity.

The role requires leading QA/QC in a regulated environment, ensuring robust quality systems, and coordinating CAPA, change controls, and QMS activities to deliver life-changing medicines with the highest

Qualifications

• Bachelor’s degree in a scientific discipline.
• At least 5 years of Quality Assurance or Quality Control experience within pharmaceutical manufacturing environments.
• Demonstrated experience leading teams and developing talent within a regulated quality organization.
• Strong knowledge of cGMP and GxP Quality requirements.
• Experience supporting audits, inspections, change controls, corrective and preventive actions, and quality systems.
• Proven ability to manage compliance risks, analyze quality metrics, and collaborate across complex organizations.

Responsibilities

• Lead day-to-day operations within the QA Compliance function and develop a high-performing quality team.
• Oversee Product Quality Review and Annual Product Quality Review planning, execution, and compliance activities.
• Support qualification and validation programs through planning, guidance, and quality review activities.
• Drive implementation and continuous improvement of quality systems, including documentation management processes.
• Coordinate corrective and preventive action activities and ensure timely follow-up on quality commitments.
• Lead audit and inspection readiness efforts, including support during regulatory and internal inspections.
• Review change controls, monitor compliance metrics, and ensure adherence to regulatory and data integrity requirements.

Skills

Quality leadership

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Audit readiness

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

CAPA tracking system

Job description

Novartis in Morris Plains, NJ, is seeking a Quality Team Leader QA Compliance to lead a high-performing team and uphold cGMP quality across operations. You will drive continuous improvement, support regulatory inspections, and partner with functions to ensure product quality and data integrity.

The role requires leading QA/QC in a regulated environment, ensuring robust quality systems, and coordinating CAPA, change controls, and QMS activities to deliver life-changing medicines with the highest