Quality Team Leader QA Compliance

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

Benefits offered by this job

Performance-based incentive

Equity awards

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis in Morris Plains, NJ, seeks a Quality Team Leader QA Compliance to lead a fast-moving team ensuring robust quality systems and patient safety. You will guide QA activities, support regulatory inspections, and drive continuous compliance improvements across the site.

You will oversee reviews, CAPA, change controls, and data integrity, ensuring adherence to cGMP and GxP standards while partnering across functions.

Qualifications

• Must have 5+ years in Quality Assurance or Quality Control in pharmaceutical manufacturing.
• Proven ability to lead teams in a regulated quality organization.
• Strong knowledge of cGMP and GxP requirements.
• Experience supporting audits, inspections, change controls, CAPA and quality systems.
• Ability to manage compliance risks and analyze quality metrics.

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 Assurance

Team Leadership

Regulatory Compliance

GxP Knowledge

Audits & Inspections

Education

Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or another scientific discipline

Job description

Job Description Summary

Location: Morris Plains, NJ, United States

Join Novartis and play a pivotal role in ensuring the highest standards of quality, compliance, and patient safety across our operations. As Quality Team Leader QA Compliance, you will lead a team responsible for maintaining robust quality systems, supporting regulatory inspections, driving continuous compliance improvements, and partnering across the organization to uphold Good Manufacturing Practice standards. This is an exciting opportunity to influence site quality performance, develop high-performing teams, and help ensure life-changing medicines are delivered to patients with the highest level of quality and integrity.

Job Description

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 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

• Bachelors 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, corrective and preventive actions, 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.
• Demonstrated experience driving quality improvements through key performance indicator analysis and compliance trending.

The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Collaboration, Data Integrity, Decision Making, Leadership, Risk Management