Quality Control Manager, Sterile

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.

• Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.

• Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities.

• Review and approve Certificates of Analysis (COAs) and ensure results meet specifications prior to product release.

• Manage quality control shop floor activities during compounding operations to ensure appropriate coverage over all shifts.

• Ensure the quality control team remains compliant with gowning, line clearance, and visual inspection competency assessments and qualifications, along with other required training.

• Provide guidance to quality control team on room clearance, line clearance and Acceptable Quality Level (AQL) inspections

• In collaboration with Microbiology, supervise viable and non-viable environmental monitoring in ISO-classified areas in accordance with USP <797>.

• Oversee personnel monitoring (gloves, gowns, fingertip sampling) and ensure compliance with established frequency and limits.

• Trend environmental monitoring data and implement corrective actions for excursions.

• Collaborate with Microbiology and Pharmacist in Charge on investigations for out-of-specification (OOS) results, sterility failures, and environmental excursions

• Conduct and document event investigations and root-cause analyses; propose and verify effectiveness of corrective and preventive actions (CAPA).

• Ensure investigations are timely, compliant, and thorough prior to seeking pharmacist approval

• Ensure quality batch record review checklists are completed in accordance with internal processes and procedures.

• Maintain accurate quality records, logs, test results, and retain sample documentation.

• Ensure data integrity principles (ALCOA+) are followed across all QC-related records.

• Support revision and creation of SOPs and work instructions related to QC operations.

• Collaborate with the microbiology manager on qualification, calibration, and maintenance of QC instruments (e.g., particle counters, incubators, pH meters, balances).

• Ensure appropriate compounding equipment logs, preventive maintenance, cleaning and calibration files are maintained and up-to-date.

• Partner with the Pharmacist in Charge and QA to support audits, mock inspections, and regulatory inspections.

• Participate in risk assessments, change controls, and continuous improvement meetings.

• Support training of pharmacy staff on quality compliance requirements and aseptic principles.

• Provide technical and shop floor support to sterile compounding personnel related to testing requirements, sampling, and product specifications.

• Ensure proper handling, storage, and disposal of testing materials, media, and reagents.

• Monitor trends to identify opportunities to enhance sterility assurance and product quality.

• Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related field.

• Minimum 3–5 years of QC experience in a sterile compounding, pharmaceutical, or biotech environment.

• Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP, and state pharmacy regulations.

• Experience with laboratory investigations, root-cause analysis, and CAPA processes.

• Demonstrated ability to interpret analytical data and laboratory test results.

• Excellent documentation skills and attention to detail.

• Experience working directly in a 503A compounding pharmacy or 503B outsourcing facility.

• Familiarity with FDA guidance on sterile compounding.

• Supervisory experience or the ability to lead and develop QC staff.

• Experience with LIMS or electronic quality systems.

• Quality-focused decision-making

• Strong problem-solving and analytical ability

• Aseptic knowledge and high attention to detail

• Effective communication and collaboration across pharmacy and quality teams

• Ability to manage multiple priorities in a fast-paced, regulated environment