Quality Team Leader QA Compliance
Novartis
August 23, 2026
On-site
Morris Plains, NJ
Operations
Key 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 (CAPA) 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.
Essential Requirements:
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Biochemistry, or another 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, CAPA, and quality systems.
- Proven ability to manage compliance risks, analyze quality metrics, and collaborate across complex organizations.
Desirable Requirements:
- Experience serving as a liaison with Health Authorities and supporting regulatory communications.
- Experience driving quality improvements through KPI analysis and compliance trending.
Compensation/Benefits:
- Salary expected to range from $114,100 to $211,900 per year; includes performance-based cash incentive and possible annual equity awards. Comprehensive benefits package and generous time off.
Application Instructions:
- For reasonable accommodations, email [email protected] or call +1(877)395-2339 (include job requisition number).
- 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 (CAPA) 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.
Essential Requirements:
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Biochemistry, or another 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, CAPA, and quality systems.
- Proven ability to manage compliance risks, analyze quality metrics, and collaborate across complex organizations.
Desirable Requirements:
- Experience serving as a liaison with Health Authorities and supporting regulatory communications.
- Experience driving quality improvements through KPI analysis and compliance trending.
Compensation/Benefits:
- Salary expected to range from $114,100 to $211,900 per year; includes performance-based cash incentive and possible annual equity awards. Comprehensive benefits package and generous time off.
Application Instructions:
- For reasonable accommodations, email [email protected] or call +1(877)395-2339 (include job requisition number).