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Compliance Pharmacist, Non-Sterile Compounding

Hims & Hers· QUALITY
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New Albany, OhioFull-timePosted 4mo ago

About the role

Designated Person (DP) for 503A pharmacy ensuring non-sterile compounding operations are compliant, inspection-ready, and patient-first. Partners with PIC to operationalize regulatory requirements, support scalable pharmacy workflows, and drive continuous quality improvements.

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 <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.

Qualifications

  • 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

Skills

Required:Regulatory complianceQuality systems & CQILicensure management

Benefits

  • 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
Last updated Aug 12, 2026. Interested? Apply on the company site.

About Hims & Hers

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