[Remote] Contract Laboratory Director & Consultant

Note: The job is a remote job and is open to candidates in USA. Celestia Diagnostics is a company focused on translating cutting-edge research in long COVID and other complex conditions into clinically validated diagnostic tests. They are seeking an experienced Contract Laboratory Director & Laboratory Consultant to provide regulatory oversight and clinical leadership while collaborating with the R&D team. Responsibilities • Ensure compliance with CLIA and applicable federal/state regulations (e.g., HIPAA, biosafety) • Review and approve the Quality Management System (plans, SOPs, policies, and QA records) • Review/approve validation or verification of new or modified LDTs and their analytical performance • Oversee proficiency testing (PT) or conduct alternative assessments where PT is unavailable • Oversee staff competency training and assessment • Maintain inspection readiness and conduct mock audits • Advise clinicians on test selection and interpretation Skills • Minimum 3 years directing or supervising high-complexity testing • Strong knowledge of quality management fundamentals and their application to blood-based quantitative assays • Excellent written and verbal communication • Based in the Southeastern US Education Requirements • Meets CLIA Laboratory Director requirements: Option 1 - MD/DO licensed and board-certified in anatomic or clinical pathology; or Option 2 - PHD in biology, laboratory science, or a related field and HHS-approved board certification (e.g., ABB, ABMM, ABCC, ABMGG) Benefits • Travel expenses reimbursed Company Overview • Diagnostics for long COVID and other infection-associated chronic conditions. It was founded in 2022, and is headquartered in Fort Worth, Texas, USA, with a workforce of 0-1 employees. Its website is https://www.celestiadiagnostics.com. Apply tot his job Apply To this Job