Compliance Pharmacist, Sterile Compounding

Compliance Pharmacist, Sterile Compounding (503A)

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. 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).

You will:

• 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

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.

You have:

• 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

Why you'll love working at Hims & Hers:

• You'll have a direct impact on patient safety and regulatory excellence
• You'll partner with smart, mission-driven teams across pharmacy and operations You'll help scale compliant, high-quality pharmacy operations in a fast-growing healthcare company