Director, End-to-End Quality - Diagnostic Testing

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

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.

Key Responsibilities

• 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).

  5. Quality Monitoring & Improvement

• 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.

• Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Clinical Laboratory Science); advanced degree preferred.

• 8–10+ years of experience in a clinical laboratory, diagnostic, or healthcare quality role, with a strong focus on CLIA-regulated testing. Experience/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.
  

• ASCP certification, Six Sigma, or quality systems certification (e.g., CQA) is a plus.
  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.

• Competitive salary & equity compensation for full-time roles

• 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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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