Hims & Hers is looking for a Director, End-to-End Quality – Diagnostic Testing to build, implement, and lead the quality systems for our CLIA-certified diagnostic testing ecosystem. Your work will span the entire patient journey, from sample collection through lab analysis and results reporting.
What You'll Do
- Design and implement a comprehensive Quality Management System (QMS) for diagnostic testing across the full workflow.
- Define, document, and manage SOPs, quality policies, and work instructions to ensure compliance with CLIA, CAP, and relevant regulations.
- Establish a diagnostic-specific governance model for quality oversight, including cross-functional collaboration.
- Lead quality oversight of pre-analytical processes like sample collection kits, transportation logistics, and sample integrity.
- Ensure controls for chain of custody, specimen stability, and patient identity protection.
- Serve as the Quality lead for relationships with internal and external CLIA-certified laboratories.
- Ensure laboratory compliance with CLIA, CAP, and state licensure.
- Support readiness for inspections and external audits by regulatory bodies.
- Oversee the quality and compliance of result reporting mechanisms, ensuring patient safety and data accuracy.
- Implement systems for post-analytical review, result validation, and reporting workflow quality assurance.
- Develop and monitor quality metrics across the diagnostic workflow.
- Lead root cause analysis and corrective/preventive actions (CAPA) for deviations and incidents.
- Champion continuous improvement initiatives across diagnostic operations.
- Hire, develop, and lead a small team of quality professionals.
- Collaborate with teams across clinical affairs, data science, engineering, product, supply chain, and customer experience.
What We're Looking For
- Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Clinical Laboratory Science).
- 8–10+ years of experience in a clinical laboratory, diagnostic, or healthcare quality role, with a strong focus on CLIA-regulated testing.
- Experience or familiarity with global regulated markets (e.g., Canada, EU).
- 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.
Nice to Have
- Advanced degree.
- ASCP certification, Six Sigma, or quality systems certification (e.g., CQA).
- Experience in telehealth, digital health, or consumer-facing diagnostic services.
- Familiarity with LIMS, QMS platforms, and tools for digital health data tracking and patient communication.
Technical Stack
- LIMS
- QMS platforms
- Tools for digital health data tracking and patient communication
Team & Environment
You will hire and lead a small team of quality professionals, with potential for future expansion. The role involves close cross-functional collaboration with Clinical, Regulatory, Operations, Customer Experience, and Product teams.
Benefits & Compensation
- Competitive salary and equity compensation
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
