Director of Toxicology
RQM+
Director, End-to-End Quality, Diagnostic Testing
hims & hers
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $190,000 - $220,000 per year
Job Level
Lead
About the role
- The Director, End-to-End Quality – Diagnostic Testing is responsible for building, implementing, and leading the quality systems, governance frameworks, and compliance processes that support Hims & Hers’ CLIA-certified diagnostic testing ecosystem. This role oversees the full diagnostic workflow—from sample collection (e.g., sample/self-collection kits), through lab processing and results reporting to patients.
- This leader will ensure compliance with CLIA, CAP, HIPAA, and state-specific laboratory regulations, while driving quality performance, risk mitigation, and operational excellence across both internal and external diagnostic partners.
- Design and implement a comprehensive Quality Management System (QMS) for diagnostic testing that spans the entire workflow: sample collection, handling, shipping, lab processing, and results delivery.
- Define, document, and manage SOPs, quality policies, and work instructions to ensure compliance with CLIA, CAP, and relevant regulatory frameworks.
- Establish a diagnostic-specific governance model for quality oversight, including cross-functional collaboration with Clinical, Regulatory, Operations, Customer Experience, and Product teams.
- Lead quality oversight of pre-analytical processes including sample/self-collection kits, transportation logistics, and sample integrity.
- Ensure appropriate controls and documentation are in place to maintain chain of custody, specimen stability, and patient identity protection.
- Serve as the Quality lead for relationships with internal and external CLIA-certified laboratories.
- Ensure that all laboratories used for diagnostic testing maintain compliance with CLIA, CAP (if applicable), and state licensure.
- Support readiness for inspections and external audits by regulatory bodies and accreditation organizations.
- Oversee the quality and compliance of result reporting mechanisms, ensuring patient safety, data accuracy, and timeliness.
- Implement systems for post-analytical review, result validation, and quality assurance of reporting workflows (including digital delivery platforms).
- Develop and monitor quality metrics across the diagnostic workflow (e.g., sample rejection rates, test TAT, invalid result rates, incident trends).
- Lead root cause analysis and corrective/preventive actions (CAPA) for deviations, complaints, and laboratory incidents.
- Champion continuous improvement initiatives across diagnostic operations.
- Hire, develop, and lead a small team of quality professionals supporting diagnostic testing. (future expansion)
- Collaborate with teams across clinical affairs, data science, engineering, product, supply chain, and customer experience to align quality practices with operational goals.
Requirements
- 8–10+ years of experience in a clinical laboratory, diagnostic, or healthcare quality role
- Proven experience building or managing QMS for diagnostic or clinical testing environments.
- Deep understanding of CLIA, CAP, HIPAA, and state lab regulatory requirements.
- Experience working across the full diagnostic lifecycle, including sample collection logistics and digital results delivery.
- Strong leadership, communication, and stakeholder engagement skills.
- Demonstrated success in cross-functional collaboration within high-growth or innovative healthcare settings.
- Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Clinical Laboratory Science); advanced degree preferred.
- ASCP certification, Six Sigma, or quality systems certification (e.g., CQA) is a plus.
- Experience in telehealth, digital health, or consumer-facing diagnostic services is a plus.
- Familiarity with LIMS, QMS platforms, and tools for digital health data tracking and patient communication.
