Compliance Pharmacist, Sterile Compounding

Hims & Hers is looking for a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee 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.

Responsibilities:

• Act as the Designee 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.

Requirements:

• 5 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>, <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:

• Prior experience serving as a Designated Person (DP) or PIC Designee.
• 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.