Senior Quality Systems Manager - Regulated IVD/GxP

Novartis; Carlsbad (NM); Vor Ort; USD 114.000 - 212.000; Vollzeit

Zusammenfassung

Novartis in Carlsbad, CA seeks a Manager, Quality Systems to oversee the Quality Management System and lead risk-based evaluation of quality data. You will drive cross-functional training, CAPA/Issues and Change Control, and ensure regulatory compliance and continuous improvement.

The role requires 7+ years in QA within regulated environments, familiarity with GxP/IVDR/QSR, and strong communication with inspectors and stakeholders. Competitive compensation and benefits are offered.

Qualifikationen

• Minimum 7 years in a related Quality Assurance role in a regulated environment.
• Experience with GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR.

Aufgaben

• Provide Quality oversight to support commercialization of IVD devices.
• Review and approve statistical frameworks, QC programs and risk assessments.
• Manage Medical Device Event Reporting and CAPA/Change Control processes.
• Evaluate quality events and advise on risk, remediation and preventive actions.
• Analyze quality data and identify trends for continual QMS improvement.
• Develop and deliver GxP, CLIA, IVD Manufacturing, ISO, GCLP training.
• Support audits and regulatory inspections; address audit observations.
• Maintain knowledge of industry standards and regulatory requirements.

Kenntnisse

Audits

cGMP Compliance

Data Integrity

Risk Management

Regulatory Compliance

Quality Assurance (QA)

Ausbildung

Bachelor's degree in engineering/medical tech/biological sciences

Jobbeschreibung

Novartis in Carlsbad, CA seeks a Manager, Quality Systems to oversee the Quality Management System and lead risk-based evaluation of quality data. You will drive cross-functional training, CAPA/Issues and Change Control, and ensure regulatory compliance and continuous improvement.

The role requires 7+ years in QA within regulated environments, familiarity with GxP/IVDR/QSR, and strong communication with inspectors and stakeholders. Competitive compensation and benefits are offered.