Cambridge, MA or Baltimore, MD

IT Quality Manager

Seniority Level

Mid-Senior

Industry

Biotech/Pharma

Employment Type

Full-time

We are seeking an IT Quality Manager to lead implementation, support, and continuous improvement of our software quality management system (QMS) and software development life cycle (SDLC) framework in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, CLIA/CAP and other applicable regulatory requirements, as well as best practices in the software industry. Successful candidates will have the opportunity to work at the cutting-edge of the cancer diagnostics industry and expand their skills in a collaborative and fast-paced environment. This is a high-impact role that will work to provide both strategic and operational excellence while helping to develop the overall technology strategy at a premier healthcare company. This high-energy individual will wear many hats and have the capacity to drive numerous complex projects forward simultaneously.

Responsibilities

  • Responsible for establishing, evolving and maintaining Thrive’s IT quality framework and procedures to ensure compliance with FDA (QSR, GXP, etc.), Data Privacy (HIPAA, HITRUST, GDPR, etc.) and CLIA regulations
  • Actively collaborate with software engineers to ensure that our software development lifecycle (SDLC) fully meets regulatory requirements with as much automation as possible
  • Provide expert guidance to technology projects on quality best practices and regulations
  • Assist with CSV (Computer System Validation) for technology projects
  • Review and disposition of validation and change control documentation
  • Conduct risk assessments and audits of external IT technology partners
  • Accountable for investigating data breaches and implementing measures for their future prevention and/or containment
  • Responsible for organizational security awareness, including staff training in collaboration with the HIPAA Privacy Officer

Qualifications

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Engineering, or related field
  • 5+ years of software design assurance in an FDA/ISO regulated environment
  • Working knowledge of applicable regulations and standards: 21CFR 820, 21CFR Part 11, ISO 13485, IEC 62304, ISO 14971, GAMP5
  • Experience with state-of-the-art SDLC tools
  • Experience working in Agile/Scrum teams
  • Able to deliver high quality results under minimal supervision in a fast-paced environment
  • Excellent independent problem-solving and analytical skills
  • Thorough understanding of HIPAA preferred
Are you qualified?

Let's do this.