Quality Systems Manager: IVD Compliance & CAPA Lead

Novartis Group Companies; Carlsbad (CA); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Generous vacation/paid time off

Job summary

Novartis Group of Companies is seeking a Manager, Quality Systems in Carlsbad, CA. You will act as a Quality SME, overseeing the Quality Management System, developing risk-based approaches for data evaluation, and translating regulatory requirements into actionable actions.

You will lead cross-functional quality training and manage CAPA/Issues, Change Control, and MDR activities in a regulated bioanalytical setting.

Qualifications

• Demonstrated ability to understand and apply risk-based practices with process analysis and root cause analysis experience.
• Experience developing procedures and training, with strong communication and collaboration skills.
• Ability to work as an independent contributor and drive continuous improvement.

Responsibilities

• Provide Quality oversight to support commercialization readiness for IVD devices.
• Review and approve statistical frameworks, programs, and deliverables including QC programs and risk assessments.
• Manage Medical Device Event Reporting and CAPA/Issues/Change Control programs.
• Evaluate quality events and provide risk-based guidance and preventive actions.
• Analyze quality data to identify issues and trends and recommend improvements to the QMS.
• Develop and deliver enterprise-wide GxP/CLIA/IVD/QMS training to ensure regulatory compliance.
• Support audits and maintain knowledge of applicable industry standards and regulatory requirements.
• Promote consistent application of regulations across Quality activities and training.

Skills

Risk-based practices

Root cause analysis

Communication

Independent contributor

Education

BS in engineering/medical technology/biological sciences

Job description

Novartis Group of Companies is seeking a Manager, Quality Systems in Carlsbad, CA. You will act as a Quality SME, overseeing the Quality Management System, developing risk-based approaches for data evaluation, and translating regulatory requirements into actionable actions.

You will lead cross-functional quality training and manage CAPA/Issues, Change Control, and MDR activities in a regulated bioanalytical setting.