Compliance Pharmacist, Sterile Compounding

Hims & Hers•Gilbert, AZ

About The Position

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). 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.

Requirements

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 and willingness to obtain reciprocal licenses in other states
Experience in sterile compounding, pharmacy compliance, or quality roles
Strong working knowledge of USP <797>, <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 Haves

Prior experience serving as a Designated Person (DP)
Board Certified Sterile Compounding Pharmacist (BCSCP) certification
Experience in high-growth or regulated healthcare environments
Background in working with cross-functional teams including quality and legal
Advanced training or certification in sterile compounding or pharmacy quality

Responsibilities

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 <797> and <800> (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

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
401k benefits with employer matching contribution
Offsite team retreats

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