Compliance Pharmacist, Sterile Compounding

Hims & Hers•New Albany, OH

8d•Remote

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 their 503A pharmacy. This role will partner closely with the Pharmacist-in-Charge (PIC) to ensure sterile compounding operations meet all applicable federal, state, and professional standards. The position is critical in maintaining a strong culture of compliance, quality, and patient safety during company scaling. This role reports to the Pharmacist-in-Charge (PIC). The Compliance Pharmacist will be responsible for ensuring the highest levels of regulatory adherence and quality assurance within the 503A sterile compounding pharmacy, serving as the primary expert on all applicable state and federal regulations, and 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
Advanced training or certification in compounding or pharmacy quality
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
Experience in pharmacy accreditation programs (VPP, ACHC, PCAB)

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.
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.