Novartis
Manager, Quality Systems
$114K–$212K
Carlsbad · Manager · Full-time · Posted Oct 15, 2026
- Experience
- Minimum of seven (7) years; no alternatives stated.
- Education
- BS in engineering, medical technology, biological sciences, or related field.
About the job
Provides Quality oversight for commercialization readiness and the Quality Management System in a regulated bioanalytical laboratory, including quality data analysis, reporting, training, audits, and quality event management.
What you'll do
- Oversee commercialization processes, statistical frameworks, manufacturing QC programs, and risk assessments for IVD devices.
- Manage Medical Device Event Reporting and support CAPA/Issues, Change Control, investigations, and quality event resolution.
- Analyze quality data, deliver regulatory and cross-functional training, and support audits and continuous improvement of the Quality Management System.
What they ask for
- BS in engineering, medical technology, biological sciences, or a related field.
- At least seven years of progressively responsible experience in a related Quality Assurance role in a regulated environment.
- Familiarity with regulatory and compliance requirements including GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, and QSR.
- Experience with risk-based practices, process and root cause analysis, and developing procedures and training.
Nice to have
- Experience with commercialization or commercialized IVD products.
- Experience with statistics or statistical frameworks, assay validation, or QC Trending.
Pay
$114,100.00 - $211,900.00 per year (base salary)
Tools
GxP, CLIA, IVD, ISO, GCLP, IVDR, Part 11, QSR
Model-written summary · the original posting is authoritative