Manager, Quality Systems

Novartis • Carlsbad, NM

4d • $114,100 - $211,900 • Onsite

About The Position

The Manager, Quality Systems serves as a Quality subject matter expert, providing oversight to support commercialization readiness and the continued effectiveness of the Quality Management System in a regulated bioanalytical laboratory environment. The role develops and maintains statistically sound, risk-based approaches for evaluating quality data, identifies emerging trends and risks, and translates regulatory requirements and quality insights into actionable recommendations. It also leads cross-functional quality and regulatory training, supports CAPA/Issues and Change Control activities, manages the Medical Device Reporting program, and provides Quality guidance during investigations and troubleshooting.

Requirements

• Bachelor of Science degree in engineering, medical technology, biological sciences, or a related field.
• At least seven years of 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.
• Ability to understand and apply risk-based practices, with process analysis and root cause analysis experience and ability to establish improved processes based on outcomes.
• Experience developing procedures and training.
• Strong communication and collaboration skills, including the ability to present data and substantiate approaches before audiences and inspectors.
• Ability to work as an independent contributor and identify and execute continuous improvement opportunities.

Nice To Haves

• Experience with commercialization or commercialized IVD products.
• Experience with statistics or statistical frameworks, assay validation, or QC Trending.

Responsibilities

• Provide Quality oversight to support commercialization readiness, including applicable processes and procedures for 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; provide guidance on risk assessment, impact, immediate remediation, and preventive actions.
• Analyze quality-related data to identify issues and emerging trends, and recommend actions to management that support Quality Management System effectiveness and continuous improvement.
• Develop and deliver enterprise-wide GxP, CLIA, IVD Manufacturing, ISO, and GCLP training to support regulatory compliance.
• 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.

Benefits

• Performance-based cash incentive.
• Potential eligibility for annual equity awards, depending on the level of the role.
• Health, life, and disability benefits for eligible US-based employees.
• 401(k) with company contribution and match.
• Vacation, personal days, holidays, and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager