Director of Quality

OverviewLightship 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 clinicalstudies. 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 LightshipParticipating in establishing various operational processes for clinical trials, including informed consent, investigator oversight, documentation, etc.Leading efforts to author and revise SOPsProactively reviewing policies, Standard Operating Procedures (SOPs), training documents, etc. and providing input related to sound business processes and compliance mattersLead and / or participant in Quality Management Reviews (QMRs)In collaboration with clinical operations personnel, establishing key performance indicators (KPIs) for clinical trialsProviding business process ownership for computerized systems as part of Lightship’s overall quality management systemProviding advice and consultation to other departments on matters related to compliance for ongoing trials; participating in trial team meetings as requestedOversee the process owner for controlled documents across LightshipLeading clinical trial risk management activities, including proactively identifying and mitigating study risks through risk analysis toolsEstablishing efficient quality oversight mechanisms for ongoing trials; providing feedback and assistance in resolving operational problemsProviding oversight for a portfolio of ongoing trialsLeading vendor audits on behalf of the companyHosting and / or participating in client audits and regulatory inspections as a subject matter expert and / or running the “war room” as requiredIdentifying areas for continuous improvement, defining improvement processes, and implementing themProviding training in various Good Clinical Practice (GCP) topicsResearching compliance and regulatory topics, synthesizing the research, and developing relevant materials addressing and / or using the researchManaging direct reportsOther duties as assignedDirector, Quality has:Required knowledge, skills, and abilitiesGood understanding of GCP and clinical trial operationsGood understanding of quality management practices in a clinical trial settingStrong written and verbal communication skillsStrong attention to detailStrong organizational skillsExcellent ability to assess riskSound judgmentAbility to collaborate effectively with various cross functional groups within the companyEducation and experienceBachelor’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 settingExperience hosting audits, preferredExperience in a Direct-to-Patient (DtP) model, preferredRequisite combination of education, training, and experience