Director, Quality

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