Compliance Pharmacist, Non-Sterile Compounding

About the role

Hims & Hers is seeking a Compliance Pharmacist to serve as the Designated Person (DP) for our 503A pharmacy. This role partners closely with the Pharmacist-in-Charge (PIC) to ensure our non-sterile compounding operations are compliant, inspection-ready, and patient-first. You’ll help operationalize regulatory requirements while supporting efficient, scalable pharmacy workflows. This role reports to the Pharmacist-in-Charge (PIC). This critical role is responsible for ensuring the highest levels of regulatory adherence and quality assurance within the 503A compounding pharmacy. The Compliance Pharmacist will serve as the primary expert on all applicable state and federal regulations, driving a culture of continuous compliance and quality excellence.

Responsibilities

• Act as the Designated Person (DP) for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area.
• Ensure active state pharmacist licensure in applicable jurisdictions and fulfill backup PIC responsibilities as needed.
• Act as a member of the CQI Committee, facilitate the CQI process according to the SOP.
• Support the PIC in maintaining pharmacy licensure, registrations, and inspection readiness.
• Ensure ongoing compliance with USP and (as applicable), state board of pharmacy requirements, and internal policies.
• Design, execute and maintain a self-inspection program for non-sterile compounding to support continuous quality improvements.
• Ensure compliant compounding practices in accordance with resident state and non-resident states in which product is being shipped to, including but not limited to meeting prescription, labeling, documentation and BUD requirements.
• Participate in investigations, root cause analyses, and CAPA activities related to quality or compliance events.
• Implement changes to ensure compliance and complete Board of Pharmacy compliance checklists as applicable.
• Oversee compliance aspects of non-sterile compounding operations, including environmental controls, cleaning, and disinfection in partnership with Quality.
• Assist in the review and approval of compounding SOPs, documentation, and records to ensure regulatory alignment.