Director, Quality

Job not on LinkedIn

November 12

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Logo of Lightship

Lightship

Biotechnology • Pharmaceuticals • Healthcare Insurance

Lightship is a company focused on making clinical trials more accessible and inclusive for all people. By designing clinical trials with flexibility in location and scheduling, Lightship expands access and choice for patients, healthcare providers, and sponsors in the clinical research space. The company aims to accelerate the development of better treatment options by leveraging inclusive technology and providing a seamless experience for participants. With a commitment to quality and equity, Lightship removes geographic barriers and collaborates with healthcare providers to deliver clinical research that improves patient outcomes.

📋 Description

• Establishing the comprehensive quality management system for clinical trials • Participating in establishing various operational processes for clinical trials • Leading efforts to author and revise Standard Operating Procedures (SOPs) • Proactively reviewing policies and providing input on compliance matters • Leading Quality Management Reviews (QMRs) • Establishing key performance indicators (KPIs) for clinical trials • Providing business process ownership for computerized systems • Providing advice on compliance matters • Overseeing controlled documents across Lightship • Leading clinical trial risk management activities • Establishing quality oversight mechanisms for ongoing trials • Leading vendor audits on behalf of the company • Hosting and/or participating in client audits and regulatory inspections • Identifying areas for continuous improvement • Providing training in Good Clinical Practice (GCP) topics • Managing direct reports • Other duties as assigned

🎯 Requirements

• 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

🏖️ Benefits

• Health insurance • 401(k) plans • Flexible work arrangements • Paid time off • Professional development

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