Manager, Quality Systems

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.

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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

The salary for this position is expected to range between $114100 and $211900 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

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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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range $114100.00 - $211900.00

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

Required Experience:

Manager