Manager, QA Method Validation

Job Description Summary

Job Description

Key Responsibilities

• Lead review and approval of method validation protocols reports and supporting data for accuracy and compliance
• Providequality 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

• Bachelors degree in engineering medical technology biological sciences or related fieldand a minimum of 8years experiencein clinical and/or GMP laboratory environments. With an advanced degree fewer years of experience may be required.
• At least 3years experiencesupporting 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 collaborationand presentation skills

Desirable Requirements

• Experience with ligand binding assays flow cytometry and digital pathology
• Proven track record of identifying and executing on continuous improvement

The salary for this position is expected to range between $114100 $211900 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 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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired