PathAI logo

Quality

Director, Quality Assurance - Biopharma Lab

Memphis, TN

PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Rigorous science and careful analysis are critical to the success of everything we aspire to do. Our team, composed of diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.

Job Summary:

The Director of Quality, Biopharm Lab Memphis is responsible for guiding the Quality team and plays an integral role in ensuring systems are established for providing high-quality services. The Director of Quality will ensure processes are aligned with regulations and standards which are compliant with the Company’s policies and procedures. The Director of Quality is responsible for owning the ongoing continuous improvement, maintenance, and execution, of the Quality Management System to support clinical trials.

Job Responsibilities:

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Manages the QA team and oversee daily QA operations
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
  • Prepares reports and/or necessary documentation (such as Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
  • Maintains a state of inspection readiness
  • Participates in other duties as needed
  • Implementation of CAP/CLIA and GCP/GCLP

Requirements

  • Minimum 10 years’ experience in medical device, IVD, or biotechnology
  • Preferred minimum 7 years experience in Quality Management System
  • Bachelor’s degree required
  • Scientific problem-solving skills using industry accepted tools
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication
  • Capability to interact with diplomacy and tact while maintaining appropriate assertiveness
  • Demonstrated ability to communicate effectively both verbally and in writing
  • Must be detail oriented, well organized, and able to work independently and in teams
  • Knowledge of CAP/CLIA and GCP/GCLP preferred. 

Benefits:

For the right candidate, we'll offer a competitive salary plus equity. Your compensation is rounded out by a strong benefits package:

  • Flexible work hours, with work-from-home options available
  • Three weeks of paid leave per year, an additional week of sick time, plus extended holidays and team-approved leave
  • Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
  • Most importantly, you'll be doing important work with a team of people you'll genuinely enjoy spending the day with.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

PathAI does not accept unsolicited submissions from third-parties.

With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.