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Director of Quality, Clinical Trial Services (CTS)

Boston, MA or Remote

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 is critical to the success of everything we aspire to do. Our team, comprising of diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.

Responsibilities:

  • Management of clinical trials quality including software development for algorithms and platforms, internal audits, and trial deployment and monitoring
  • Management of a team of software professionals and internal auditors
  • Represent PathAI as the face of quality for customer interactions
  • Strategic planning for multiple trials, including some interfaces with PathAI Biopharm Lab
  • Responsible for ensuring compliance to GCP/GCLP through rigorous monitoring, verification, and validation programs
  • Responsible for review and approval of SOWs, SOPs, Analytical Plans and all associated trial documentation to ensure successful deployments. 

Requirements:

  • 8 years or more experience in domestic and international quality management / regulatory compliance working under GCP and/or GCLP
  • Experience in diagnostic instrumentation and/or diagnostic image analysis products 
  • Working knowledge of software development life cycles described in IEC 62304 
  • Strong interpersonal and relationship building skills, with special emphasis on the ability to effectively execute projects and provide guidance involving multiple internal and external stakeholders and decision makers 
  • Excellent and adaptable analytical, organizational and communication skills 
  • BS Degree in engineering, physical, or life science 
  • Experience with BIMO inspections 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 two weeks of sick time, plus extended holidays and team-approved leave
  • Ten days of 100% subsidized childcare per year
  • Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
  • Commuter benefit available for public transit or parking

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.