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Director, Quality

Remote

Overview 

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical

studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house care team ensure sponsor success and the best possible patient experience.

With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.

The Director, Quality is an individual with experience in establishing processes associated with executing clinical trials. This individual is expected to apply a systems thinking approach via a strong background in and history of successfully building and maintaining efficient quality systems. The Director, Quality works in a pivotal role collaborating with technology and clinical study personnel establishing the quality management systems applicable across all Lightship’s clinical trials.

This position is remote, and a successful candidate will possess a willingness and desire to work independently without significant oversight. Additionally, this position may require some travel.

 

The Director, Quality is responsible for: 

  • Under the direction of the Chief Business Officer, establishing the comprehensive quality management system for clinical trials at Lightship
  • Participating in establishing various operational processes for clinical trials, including informed consent, investigator oversight, documentation, etc.
  • Leading efforts to author and revise SOPs
  • Proactively reviewing policies, Standard Operating Procedures (SOPs), training documents, etc. and providing input related to sound business processes and compliance matters
  • Lead and / or participant in Quality Management Reviews (QMRs) 
  • In collaboration with clinical operations personnel, establishing key performance indicators (KPIs) for clinical trials
  • Providing business process ownership for computerized systems as part of Lightship’s overall quality management system
  • Providing advice and consultation to other departments on matters related to compliance for ongoing trials; participating in trial team meetings as requested
  • Oversee the process owner for controlled documents across Lightship
  • Leading clinical trial risk management activities, including proactively identifying and mitigating study risks through risk analysis tools
  • Establishing efficient quality oversight mechanisms for ongoing trials; providing feedback and assistance in resolving operational problems
  • Providing oversight for a portfolio of ongoing trials
  • Leading vendor audits on behalf of the company
  • Hosting and / or participating in client audits and regulatory inspections as a subject matter expert and / or running the “war room” as required
  • Identifying areas for continuous improvement, defining improvement processes, and implementing them
  • Providing training in various Good Clinical Practice (GCP) topics
  • Researching compliance and regulatory topics, synthesizing the research, and developing relevant materials addressing and / or using the research
  • Managing direct reports
  • Other duties as assigned

 

Director, Quality has:

  • Required knowledge, skills, and abilities
    • Good understanding of GCP and clinical trial operations
    • Good understanding of quality management practices in a clinical trial setting
    • Strong written and verbal communication skills
    • Strong attention to detail
    • Strong organizational skills
    • Excellent ability to assess risk
    • Sound judgment
    • Ability to collaborate effectively with various cross functional groups within the company

 

  • Education and experience
    • Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline; or requisite combination of education, training, and experience.
    • 10 plus years of experience in a clinical trial, healthcare, or life science setting
    • Experience hosting audits, preferred
    • Experience in a Direct-to-Patient (DtP) model, preferred
    • Requisite combination of education, training, and experience

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