Manager, Quality Systems

Novartis•Carlsbad, NM

25d•$114,100 - $211,900•Onsite

About The Position

The Manager, Quality Systems will serve as a Quality subject matter expert, providing oversight to support commercialization readiness and the continued effectiveness of the Quality Management System. The role develops and maintains statistically sound, risk-based approaches for evaluating quality data, identifies emerging trends and risks, and translates regulatory requirements and quality insights into actionable recommendations. It also leads cross-functional quality and regulatory training, supports CAPA/Issues and Change Control activities, manages the Medical Device Reporting program, and provides Quality guidance during investigations and troubleshooting within a regulated bioanalytical laboratory environment.

Requirements

Bachelor of Science 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.
Experience and familiarity with regulatory and compliance requirements and guidelines, including GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, and QSR.
Ability to understand and apply risk-based practices; experience with process analysis and root cause analysis; and ability to establish improved processes based on outcomes.
Experience developing procedures and training.
Strong communication and collaboration skills, including ability to present data and substantiate approaches before audiences and inspectors.
Ability to work as an independent contributor and identify and execute continuous improvement opportunities.

Nice To Haves

Experience with commercialization or commercialized IVD products.
Experience with statistics or statistical frameworks, assay validation, or QC trending.

Responsibilities

Provide Quality oversight for commercialization readiness, including processes and procedures for commercializing IVD devices.
Review and approve statistical frameworks, programs, and deliverables, including manufacturing QC programs and risk assessments.
Manage the Medical Device Event Reporting process and support CAPA/Issues and Change Control programs in accordance with internal procedures and regulatory requirements.
Evaluate quality events, including deviations, CAPAs, complaints, audit findings, OOS, NCMR, and OOR; provide guidance on risk assessment, impact, immediate remediation, and preventive actions.
Analyze quality data to identify issues and emerging trends and recommend actions that support Quality Management System effectiveness and continuous improvement.
Develop and deliver enterprise-wide GxP, CLIA, IVD Manufacturing, ISO, and GCLP training.
Support clinical laboratory compliance with applicable accreditation requirements and support internal, sponsor, and regulatory audits, including resolving assigned audit observations.
Maintain current knowledge of applicable industry standards and regulatory requirements, including IVDR, MDCG 2024-4, ISO, CLIA/CAP, QSR, GCP/GCLP, cGMP, and ICH, and promote their consistent application across Quality activities and training.