Manager, QA Method ValidationU441 (FCRS = US441) Navigate BioPharma Services, Inc. • Carlsbad, California, United States

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Manager, QA Method Validation

U441 (FCRS = US441) Navigate BioPharma Services, Inc.

Carlsbad, California, United States

Carlsbad, California, United States

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Job Description Summary Location: Carlsbad, United States. You’ll play a critical role at the intersection of quality, innovation, and patient impact—leading laboratory method validation for assays and devices used in clinical and GMP laboratory settings. Relocation Support This role is based in Carlsbad, California. Novartis is unable to offer relocation support: please only apply if accessible. Key Responsibilities Lead review and approval of method validation protocols, reports, and supporting data for accuracy and compliance. Provide quality guidance on analytical method validations/verifications, troubleshooting, and impact assessments. Serve as Quality representative on in vitro diagnostic design teams. Evaluate and provide guidance on risk assessments, impact assessment, deviations, and corrective actions. Ensure adherence to regulatory and company requirements. Lead and/or support audits and inspections including preparation and follow‑up. Assist with quality management of technology transfer. Maintain oversight of documentation, procedures, and training compliance. Essential Requirements Bachelor’s degree in engineering, medical technology, biological sciences, or related field and a minimum of 8 years’ experience in clinical and/or GMP laboratory environments. Advanced degree may reduce required years of experience. At least 3 years of experience supporting in‑vitro diagnostic development. Experience, understanding, and familiarity with regulatory requirements and compliance guidelines such as GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR. Basic understanding of molecular biology, immunology, immunohistochemistry, flow cytometry, fluorescent in situ hybridization. Familiarity with statistical analysis. Strong communication, collaboration, and presentation skills. Desirable Requirements Experience with ligand binding assays, flow cytometry, and digital pathology. Proven track record of identifying and executing continuous improvement initiatives. Salary and Benefits 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 relevant skills and experience and will be reviewed periodically. 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. 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 reasonableaccommodations@novartis.com 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.
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Carlsbad, California, United States

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English

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