Compliance Pharmacist, Sterile Compounding

Compliance Pharmacist, Sterile Compounding 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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: Hims & Hers is looking for a Compliance Pharmacist with sterile compounding expertise to serve as the Designated Person (DP) for sterile compounding at our 503A pharmacy. In this role, you’ll partner closely with the Pharmacist-in-Charge (PIC) to ensure our sterile compounding operations meet all applicable federal, state, and professional standards. You’ll play a critical role in maintaining a strong culture of compliance, quality, and patient safety as we continue to scale. This role reports to the Pharmacist-in-Charge (PIC). YOU WILL: - Act as the Designated Person (DP) for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area. - Act as a member of the CQI Committee, facilitate the CQI process according to the SOP. - 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 sterile compounding to support continuous quality improvements. - Implement changes to ensure compliance and complete Board of Pharmacy compliance checklists as applicable. - Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness and recordkeeping - Oversee compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality. - Assist in the review and approval of sterile compounding SOPs, documentation, and records to ensure regulatory alignment - Monitor regulatory changes and assess operational impact; partner with stakeholders to implement updates - Support environmental monitoring, personnel qualification, media fills, and competency programs in partnership with training and quality departments. - Participate in investigations, root cause analyses, and CAPA development related to deviations or quality events - Prepare for and support state board inspections, internal audits, and third-party assessments - Ensure training programs and competencies are in line with regulatory standards and appropriately documented - Track and ensure timely resolution of inspection findings and audit observations - Partner cross-functionally with pharmacy operations, quality, and leadership to proactively manage compliance risks - Escalate significant compliance issues and trends to the PIC as appropriate This critical role is responsible for ensuring the highest levels of regulatory adherence and quality assurance within the 503A sterile 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. YOU HAVE: - 2 years of Sterile compounding experience - Pharmacy degree from an ACPE-accredited school of pharmacy - Active, unrestricted Pharmacist license in the state of practice - Eligibility ... (truncated, view full listing at source)