Compliance Pharmacist, Sterile Compounding

Hims & Hers•Mesa, AZ

About The Position

Hims & Hers is seeking a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for sterile compounding at its 503A pharmacy. The role partners closely with the Pharmacist-in-Charge (PIC) to ensure sterile compounding operations comply with applicable federal, state, and professional standards, and supports a culture of compliance, quality, and patient safety as the company scales. The position reports to the Pharmacist-in-Charge (PIC). The Compliance Pharmacist serves as a designee for the 503A pharmacy in the applicable functional area and supports the PIC with regulatory compliance, pharmacy licensure, registrations, readiness, and recordkeeping. The role oversees compliance aspects of sterile compounding, including aseptic technique, environmental controls, cleaning, and disinfection, in partnership with Quality. It also supports self-inspections, audits, inspections, environmental monitoring, personnel qualification, media fills, competency programs, and investigations and corrective actions. The pharmacist monitors regulatory changes, helps translate requirements into practical processes, and partners with pharmacy operations, quality, and leadership to address compliance risks.

Requirements

Five years of sterile compounding experience.
Pharmacy degree from an ACPE-accredited school of pharmacy.
Board Certified Sterile Compounding Pharmacist (BCSCP) certification.
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>, USP <800>, and state board of pharmacy regulations applicable to 503A pharmacies.
Experience supporting audits, inspections, or regulatory inquiries.
Excellent attention to detail and 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) or PIC Designee.
Experience in high-growth or regulated healthcare environments.
Background working with cross-functional teams, including quality and legal.
Advanced training or certification in sterile compounding or pharmacy quality.

Responsibilities

Act as the designee for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area.
Maintain active state pharmacist licensure in applicable jurisdictions and fulfill backup PIC responsibilities as needed.
Serve as a member of the CQI Committee and 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 sterile compounding self-inspection program to support continuous quality improvement.
Implement changes to ensure compliance and complete Board of Pharmacy compliance checklists as applicable.
Support the PIC in maintaining pharmacy licensure, registrations, 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 reviewing and approving sterile compounding SOPs, documentation, and records for regulatory alignment.
Monitor regulatory changes, assess operational impact, and 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 align with regulatory standards and are appropriately documented.
Track and ensure timely resolution of inspection findings and audit observations.
Partner with pharmacy operations, quality, and leadership to proactively manage compliance risks.
Escalate significant compliance issues and trends to the PIC as appropriate.
Travel as needed.