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Director, Quality Assurance - Biopharma Lab



Quality Assurance
Memphis, TN, USA
Posted on Thursday, April 13, 2023

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.

Where You Fit

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.

What You’ll Do

  • 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

What You Bring

  • 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.

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.

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.