Manager, Quality Systems
Novartis
Summary
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. This role will develop and maintain statistically sound, risk-based approaches for evaluating quality data, identify emerging trends and risks, and translate regulatory requirements and quality insights into actionable recommendations. The position will also lead cross-functional quality and regulatory training, support CAPA/Issues and Change Control activities, manage the Medical Device Reporting program, and provide Quality guidance during investigations and troubleshooting within a regulated bioanalytical laboratory environment.
Job description
Key Responsibilities
- Provide Quality oversight to support commercialization readiness, including applicable processes and procedures for the 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, providing guidance on risk assessment, impact, immediate remediation, and preventive actions.
- Analyze quality-related data to identify issues and emerging trends and provide recommendations 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.
Essential Requirements
- BS in engineering, medical technology, biological sciences, or related field.
- Minimum of seven (7) years 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.
- Demonstrated 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, with strong communication and collaboration skills and the ability to present data and substantiate approaches before audiences and inspectors.
- Ability to work as an independent contributor, identifying and executing continuous improvement opportunities.
Desirable Requirements
- Experience with commercialization or commercialized IVD products
- Experience with statistics or statistical frameworks, assay validation, or QC Trending
Requirements
- BS in engineering, medical technology, biological sciences, or related field.
- Minimum of seven (7) years 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.
- Demonstrated 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, with strong communication and collaboration skills and the ability to present data and substantiate approaches before audiences and inspectors.
- Ability to work as an independent contributor, identifying and executing continuous improvement opportunities.
- Experience with commercialization or commercialized IVD products
- Experience with statistics or statistical frameworks, assay validation, or QC Trending
Benefits
- Health insurance
- Life insurance
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Performance-based cash incentive
- Annual equity awards
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.