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Compliance Pharmacist, Non-Sterile Compounding

hims & hers

Compliance Pharmacist

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 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).

You Will:

  • 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 <795> and <800> (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
  • Monitor regulatory changes and assess operational impact; partner with stakeholders to implement updates
  • Prepare for and support state board inspections, internal audits, and third-party assessments
  • Partner cross-functionally with pharmacy operations, quality, and leadership to proactively manage compliance risks
  • Act as a liaison to roll out and facilitate implementation of new initiatives, system upgrades, corrective actions and new therapies.
  • Escalate significant compliance or patient safety issues and trends to the PIC as appropriate
  • Review and confirm training and competencies align with regulatory standards.

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.

You Have:

  • 2 years of Compounding experience
  • Pharmacy degree from an ACPE-accredited school of pharmacy
  • Active, unrestricted Pharmacist license in the state of practice
  • Eligibility and willingness to obtain reciprocal licenses in other states
  • Experience in compounding, pharmacy compliance, or quality roles
  • Strong working knowledge of USP <795> , <800> , and state board of pharmacy regulations applicable to 503A pharmacies
  • Experience supporting audits, inspections, or regulatory inquiries
  • Excellent attention to detail with strong documentation and organizational skills
  • Ability to translate regulatory requirements into practical, scalable processes
  • Willingness to travel

Nice to Have:

  • Experience serving as a Designated Person (DP)
  • Experience in high-growth, regulated healthcare or pharmacy environments
  • Experience supporting mail-order or high-volume fulfillment operations
  • Background in quality systems or continuous improvement initiatives

Our Benefits (there are more but here are some highlights):

  • 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
hims & hers
Vacancy posted 5 days ago
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