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Manager, Quality SystemsNovartis · Carlsbad
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Novartis

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Manager, Quality Systems

🗓️ Posted 2026-10-15 Carlsbad Hybrid Healthcare Medical
💰 Salary 9,508 CHF–17,658 CHF/mo (114,100 CHF–211,900 CHF/yr) 📊 Market NA

About the Company

Job Description Summary Location: Carlsbad, California 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. LI-OnSite 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,

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.
  • ● 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.
  • ● Ability to work as an independent contributor, identifying and executing continuous improvement opportunities.
  • ● The salary for this position is expected to range between 114,100 and 211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
  • ● To learn more about the culture, rewards and benefits we offer our people click here.
  • ● EEO Statement:
  • ● The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
  • ● Accessibility and reasonable accommodations
  • ● The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
  • ● Salary Range 114,100.00 - 211,900.00