Manager, Quality Systems

DTX Pharma, a Novartis Company; Carlsbad (CA); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis in Carlsbad, CA seeks a Manager of Quality Systems to act as a Quality subject matter expert, overseeing the QMS, evaluating data, identifying trends, and translating regulatory requirements into actionable recommendations. You will lead cross-functional training, support CAPA/Issues and Change Control, and guide MDR programs within a regulated bioanalytical lab.

The role requires a BS in a relevant field and 7+ years in QA within regulated environments, with experience in GxP, IVDR,

Qualifications

• BS in engineering, medical technology, biological sciences, or related field.
• Experience with regulatory and compliance requirements and guidelines (GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR).
• Ability to apply risk-based practices and perform root cause analysis.

Responsibilities

• Provide Quality oversight to support commercialization readiness and QMS effectiveness.
• Review and approve statistical frameworks and QC programs; manage risk assessments.
• Lead CAPA/Issues and Change Control processes; manage Medical Device Event Reporting.

Skills

Quality Assurance

Regulatory Compliance

Risk Analysis

Root Cause Analysis

Data Analysis

Education

BS in Engineering/Medical Technology/Biology

Job description

Band

Level 4

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.

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

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$114,100.00 - $211,900.00

Skills Desired

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