Manager, Quality Systems

Novartis•Carlsbad, CA

23d•Onsite

About The Position

The Manager, Quality Systems serves 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 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. The position is based in Carlsbad, California, and is identified as on-site. The expected salary range is $114,100 to $211,900 per year. Compensation includes a performance-based cash incentive and, depending on role level, potential eligibility for annual equity awards. Eligible US-based employees receive health, life and disability benefits, a 401(k) with company contribution and match, and time off including vacation, personal days, holidays, and other leaves.

Requirements

Bachelor of Science degree 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, understanding, 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, with process analysis and root cause analysis experience and the ability to establish improved processes based on outcomes.
Experience developing procedures and training.
Strong communication and collaboration skills, including the 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 to support commercialization readiness, including applicable processes and procedures for commercialization of IVD devices.
Provide Quality oversight, review, and approval of 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 applicable regulatory requirements.
Evaluate quality events—including deviations, CAPAs, complaints, audit findings, OOS, NCMR, and OOR—and provide guidance on risk assessment, impact, immediate remediation, and preventive actions.
Analyze quality-related data to identify issues and emerging trends and recommend actions to management that support the effectiveness and continuous improvement of the Quality Management System.
Develop and deliver enterprise-wide GxP, CLIA, IVD Manufacturing, ISO, and GCLP training to ensure compliance with regulatory requirements.
Support clinical laboratory compliance with applicable accreditation requirements and support internal, sponsor, and regulatory audits, including managing assigned audit observations through resolution.
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.