New · posted Oct 16
Novartis · Medical Devices
Manager, Quality Systems
- Carlsbad, CA
- On-site
- Full-time
- Manager
Open until filled
The role
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.
What you need
- 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
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.
Skills Desirednice to have
Audits Compliance, cGMP Compliance, Collaboration, Communication, Data Integrity, Decision Making, Internal Auditing, Managing Ambiguity, Problem Solving, Quality Assurance (QA), Quality Auditing, Quality Compliance, Quality Management, Quality Management System Implementation, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Validation Activities
What you'll do
- 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.
Pay and benefits
$114,100 – $211,900 a year
Employer provided$114,100.00 - $211,900.00
Health, life and disability benefits
401(k) with company contribution and match
Performance-based cash incentive
Eligibility for annual equity awards
Paid time off including vacation, personal days and holidays
Where you'll work
Carlsbad, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Carlsbad, CAEqual opportunity, accessibility and legal noticesNovartis's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California26 roles publishing pay
Manager roles in the US104 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $114,100 | — | $211,900 |
| California (middle half) | $156,375 | $165,500 | $181,000 |
| All US (middle half) | $127,125 | $154,000 | $167,625 |
This role: Novartis's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Novartis's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk7
- GMP and compliance6
- Collaboration and leadership5
- Investigations and CAPA4
- Lab testing and methods3
- Documentation and SOPs3
- Data and digital systems3
- Validation and qualification2
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
Company hiring pulse
Novartis on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 6
- Locations
By discipline
- Quality10 83%
- Compliance & Safety2 17%
By level
- Senior & Principal5 42%
- Associate & Specialist4 33%
- Director2 17%
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Manager, Quality Systems at Novartis
Open until filled. $114K–$212K a year, employer provided.