Director, Quality Assurance Lead

5 days ago

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

Karius, Inc. is a pioneering life science company that is revolutionizing the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, and ultimately reduce patient suffering worldwide.

Position Summary

The Director, Quality Assurance will lead all quality activities at Karius, Inc. This person will collaborate with all functions to manage a quality system to support the company's diagnostic assay development activities, ultimately resulting in systems that are both FDA-QSR compliant as well as CLIA/CAP compliant. This person will additionally define and build the quality team, and lead them in the operation and management of the quality function. The ideal candidate will have experience building such systems from the ground up, and be comfortable operating in a fast-paced startup environment.

Responsibilities
  • Define and build the quality team that will be needed to achieve company goals.
  • Lead the implementation, management, and operation of Karius, Inc.'s 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, Inc.'s 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, Inc. 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's Fun About the Job?

Karius, Inc. is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Travel

Travel required up to 10%.

Physical Requirements

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.

Position 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.
Personal Qualifications
  • Excellent written and verbal communication skills.
  • Ability to proactively communicate in a consistent, clear, and honest manner.
  • Flexible and adaptive in a frequently changing environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated with a strong sense of ownership in areas of responsibility.

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