Manager, QA Method Validation

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 plus at least 8 years’ experience in clinical and/or GMP laboratory environments (advanced degree may reduce required years)
- At least 3 years experience supporting in vitro diagnostic development
- Familiarity with regulatory/compliance requirements and guidelines (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
- Track record of continuous improvement

Application/Location:
- Role based in Carlsbad, California; Novartis is unable to offer relocation support (apply only if accessible).