Manager, QA Method Validation

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. With an advanced degree, fewer years of experience may be required.
• At least 3 years experience supporting in vitro diagnostic development
• Experience, understanding, and familiarity with regulatory requirements and other compliance requirements and 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 on continuous improvement
• To learn more about the culture, rewards and benefits we offer our people click here .
• #LI-Onsite
• EEO Statement:
• Accessibility and reasonable accommodations
• Salary Range
• $114,100.00 - $211,900.00
• Skills Desired
• Collaboration, Communication Skills (Inactive), Data Integrity, Decision Making, Digital saviness (Inactive), Leadership, Managing Ambiguity, Organizational Saviness (Inactive), Regulatory Requirements knowledge (Inactive), Risk Management

Benefits

Additional Information

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. As a trusted quality leader, you will shape how analytical methods are brought to life in a highly regulated environment, partnering closely with scientific and cross-functional teams to solve complex challenges, strengthen compliance, and enable the delivery of high-quality data that supports breakthrough therapies. Relocation Support: This role is based in Carlsbad, California. Novartis is unable to offer relocation support: please only apply if accessible. Job Description

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