QA Compliance Lead: Quality Systems & GMP Readiness

Novartis Group Companies; Morris Plains (NJ); On-site; USD 114,100 - 211,900; Full time

Job summary

Novartis Group of Companies in Morris Plains, NJ, is seeking a Quality Team Leader QA Compliance to lead a high-performing team ensuring robust quality systems and regulatory readiness. You will drive continuous improvement, support inspections, and oversee CQAs and change controls to uphold data integrity and patient safety.

The role requires a Bachelor’s degree in a scientific discipline and at least 5 years of QA/QC experience in pharma manufacturing, with strong cGMP knowledge and leadership

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology).
• Minimum 5 years QA/QC experience in pharmaceutical manufacturing.
• Experience leading teams in a regulated quality organization.
• Strong knowledge of cGMP and GxP quality requirements.

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

Collaboration

Data Integrity

Decision Making

Leadership

Risk Management

Education

Bachelor’s degree in a scientific discipline

Job description

Novartis Group of Companies in Morris Plains, NJ, is seeking a Quality Team Leader QA Compliance to lead a high-performing team ensuring robust quality systems and regulatory readiness. You will drive continuous improvement, support inspections, and oversee CQAs and change controls to uphold data integrity and patient safety.

The role requires a Bachelor’s degree in a scientific discipline and at least 5 years of QA/QC experience in pharma manufacturing, with strong cGMP knowledge and leadership