QA Lead: QC Operations & Compliance

U469 (FCRS = US469) AAA USA Inc.; Millburn (NJ); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis is seeking a QA professional to provide quality oversight across Quality Control testing activities and partner with laboratory teams to ensure data integrity and compliance. You will review critical records, support investigations and change control, and drive operational excellence in laboratory operations.

The role requires a Bachelor’s degree in a scientific field and several years in pharma QA/QC, with strong GMP knowledge and cross-functional collaboration.

Qualifications

• Bachelor’s degree or higher in a scientific discipline.
• Several years of experience in pharmaceutical quality assurance, quality control, or manufacturing environments.
• Strong knowledge of GMP, quality systems, and regulatory compliance.

Responsibilities

• Provide quality assurance oversight for Quality Control testing activities to ensure compliance and inspection readiness.
• Partner with laboratory teams to promote data integrity, electronic compliance, and quality standards.
• Review and approve Quality Control and Analytical Science and Technology records accurately and timely.
• Support and assess investigations related to Quality Control deviations and quality events.
• Review and support change control activities impacting Quality Control processes and systems.
• Contribute to operational excellence and continuous improvement initiatives across laboratory operations.
• Promote a strong safety culture through compliance with Health, Safety, and Environment requirements.

Skills

Collaboration

Communication

Data Integrity

GMP

Internal Quality Auditing

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

Quality Management Systems

Regulatory Compliance

SOP

SPC

English Proficiency

Education

Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or related

Job description

Novartis is seeking a QA professional to provide quality oversight across Quality Control testing activities and partner with laboratory teams to ensure data integrity and compliance. You will review critical records, support investigations and change control, and drive operational excellence in laboratory operations.

The role requires a Bachelor’s degree in a scientific field and several years in pharma QA/QC, with strong GMP knowledge and cross-functional collaboration.