Director, External Lab Quality & Testing Performance - Remote Eligible

Director of External Lab Quality & Testing Performance

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.

We are looking for a highly strategic and detail-oriented Director of External Lab Quality & Testing Performance to lead and oversee all contract testing laboratories supporting Hims & Hers' 503A and 503B compounding pharmacy operations. In this role, you'll ensure testing partners meet regulatory standards, deliver timely results, and drive continuous improvement across lab performance and quality systems.

This is a critical leadership position that requires deep experience in cGMP environments, strong cross-functional collaboration, and a proven track record managing third-party laboratory partners. You'll serve as a key point of contact between internal stakeholders and external labs, championing quality, compliance, and performance across the testing value chain.

You will:

• Lead third-party lab oversight: Manage quality oversight of external labs performing analytical, microbiological, sterility, stability, and other testing for 503A and 503B operations.
• Ensure compliance: Ensure labs operate in accordance with all contractual, cGMP, FDA, USP, DEA, and state board requirements, and maintain audit readiness at all times.
• Drive cross-functional collaboration: Work closely with Quality, Manufacturing, Supply Chain, and R&D teams to align priorities, testing logistics, and release timelines.
• Own performance metrics: Define and track KPIs for lab performance, including turnaround time, investigation cycle time, throughput, and capacity utilization.
• Manage investigations: Oversee quality investigations related to third-party lab performance, including OOS/OOT events and CAPA implementation, ensuring timely resolution and documentation.
• Support audits & inspections: Represent the company during audits or inspections involving external labs.
• Maintain quality agreements: Develop and manage quality agreements with contract laboratories, ensuring clear responsibilities and alignment with internal risk and compliance frameworks.
• Lead continuous improvement: Identify process inefficiencies and risks, lead improvement initiatives, and champion innovation in digital lab tracking and reporting systems.
• Conduct business reviews: Facilitate regular lab performance reviews with internal and external stakeholders using data-driven insights.

You have:

• Bachelor's or advanced degree in Chemistry, Biology, Pharmaceutical Sciences, or related field.
• 8–10 years of experience in a cGMP-regulated quality environment, including 3–5 years in a leadership role managing lab or vendor operations.
• Direct experience supporting 503A and/or 503B compounding operations.
• Strong understanding of USP <797>, <800>, and relevant FDA cGMP guidelines (21 CFR Part 210/211, 503B).
• Proven success managing external vendors and implementing performance improvement programs.
• Strong communication, analytical, and project management skills.
• Proficiency in tools for investigation and quality systems (e.g., 5 Whys, fishbone diagrams, Excel, Power BI).
• Familiarity with LIMS, EDMS, or other lab/sample tracking tools is a plus.
• Experience with sterile product testing and environmental monitoring is preferred.
• Comfort representing the company during regulatory audits is a strong advantage.

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.