Director of Quality Assurance

4 weeks ago

Redwood City, California, United States Karius, Inc. Full time
About the Role

Karius, Inc. is seeking a highly experienced Director of Quality Assurance to lead all quality activities at our company. This individual will collaborate with all functions to manage a quality system that supports our diagnostic assay development activities, ensuring compliance with FDA-QSR and CLIA/CAP regulations.

The ideal candidate will have experience building quality systems from the ground up and be comfortable operating in a fast-paced startup environment. They will define and build the quality team, lead them in the operation and management of the quality function, and ensure continuous improvement of QA systems and processes.

This role requires a strong understanding of diagnostic assay development and production processes, as well as experience with implementation, management, and operation of FDA-compliant and LDT quality systems. The successful candidate will be able to lead cross-functional teams and manage complex projects in a fast-paced startup environment.

Key Responsibilities
  • Define and build the quality team that will be needed to achieve company goals.
  • Lead the implementation, management, and operation of Karius' quality function for compliance with both FDA-QSR and CLIA/CAP/NYSDOH.
  • Develop and plan innovative quality and regulatory strategies in life cycle product management for clinical metagenomic tests.
  • Manage all aspects of the quality assurance lifecycle, including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, corrective and preventive actions (CAPA), and closing.
  • Promote awareness across the commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified.
  • Ensure continuous improvement of the QA systems and processes, by establishing Key Performance Indicators to monitor compliance and efficiency.
  • Collaborate with R&D, product, manufacturing, clinical, and regulatory teams to ensure quality standards are integrated throughout the product life cycle.
  • Work closely with other departments to address quality issues and implement CAPA.
  • Ensure CAPA identified during audits to address compliance concerns identified during audits are commensurate with current industry practices and benchmarks.
  • Develop Karius' global quality policy & standards, supporting the company mission to deliver unprecedented insight to enable clinicians to make rapid life-saving treatment decisions.
  • Act as technical expert in quality processes, guiding cross-functional teams in process development, evaluation, and continuous improvement.
  • Work across teams to ensure efforts are synchronized with Karius quality procedures, resulting in a single harmonized quality function for the company.
  • Lead batch record review, lot disposition, material release, internal audit program, deviation handling, change controls, and quality events processes.
What We Offer

Karius, Inc. is a dynamic and innovative company that offers a unique opportunity to work at the edge of what is now known to be possible in infectious disease diagnostics. We are committed to delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood.

We are seeking a highly experienced Director of Quality Assurance to join our team and contribute to our mission to conquer infectious diseases through innovations around genomic sequencing and machine learning.

The successful candidate will have the opportunity to work with a talented team of scientists, statisticians, engineers, and physicians who are driven by the same mission to deliver life-changing impact on people, and at scale.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Requirements
  • 8+ years of Quality Management, Quality Assurance, and Quality Control leadership experience in Diagnostics, Biotechnology, or relatable life sciences fields.
  • Regulatory experience is highly preferred.
  • BS in molecular biology, microbiology or related field; advanced degree (MS/PhD) preferred.
  • Experience with implementation, management and operation of FDA-compliant and LDT quality systems. ISO 13485 experience a plus.
  • Experience in a quality assurance role, bringing an In-Vitro Diagnostic (IVD) product (or products) through the FDA process.
  • Experience preparing for and managing audit visits by certification bodies or regulators, demonstrated by successful completion of audits or successful certification.
  • Strong understanding of diagnostic assay development and production processes.
  • Demonstrated ability to lead cross-functional teams and manage complex projects in a fast-paced startup environment. Excellent communication and interpersonal skills.

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