Quality Systems Leader — Regulatory & CAPA Insights

DTX Pharma, a Novartis Company; Carlsbad (CA); Vor Ort; USD 114.000 - 212.000; Vollzeit

Benefits dieser Stelle

Health, life and disability benefits

401(k) with company match

Generous time off

Zusammenfassung

Novartis in Carlsbad, CA seeks a Manager of Quality Systems to act as a Quality subject matter expert, overseeing the QMS, evaluating data, identifying trends, and translating regulatory requirements into actionable recommendations. You will lead cross-functional training, support CAPA/Issues and Change Control, and guide MDR programs within a regulated bioanalytical lab.

The role requires a BS in a relevant field and 7+ years in QA within regulated environments, with experience in GxP, IVDR,

Qualifikationen

• BS in engineering, medical technology, biological sciences, or related field.
• Experience with regulatory and compliance requirements and guidelines (GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR).
• Ability to apply risk-based practices and perform root cause analysis.

Aufgaben

• Provide Quality oversight to support commercialization readiness and QMS effectiveness.
• Review and approve statistical frameworks and QC programs; manage risk assessments.
• Lead CAPA/Issues and Change Control processes; manage Medical Device Event Reporting.

Kenntnisse

Quality Assurance

Regulatory Compliance

Risk Analysis

Root Cause Analysis

Data Analysis

Ausbildung

BS in Engineering/Medical Technology/Biology

Jobbeschreibung

Novartis in Carlsbad, CA seeks a Manager of Quality Systems to act as a Quality subject matter expert, overseeing the QMS, evaluating data, identifying trends, and translating regulatory requirements into actionable recommendations. You will lead cross-functional training, support CAPA/Issues and Change Control, and guide MDR programs within a regulated bioanalytical lab.

The role requires a BS in a relevant field and 7+ years in QA within regulated environments, with experience in GxP, IVDR,