Compliance Pharmacist, Sterile Compounding

The role

The Compliance Pharmacist ensures regulatory adherence and quality assurance within the 503A sterile compounding pharmacy. This person acts as the Designee for the pharmacy and manages compliance with USP and state board requirements.

What you will do

• Act as the Designee for the 503A pharmacy in accordance with applicable regulations and USP.
• Ensure active state pharmacist licensure and fulfill backup PIC responsibilities.
• Act as a member of the CQI Committee and facilitate the CQI process.
• Ensure ongoing compliance with USP, state board of pharmacy requirements, and internal policies.
• Design, execute and maintain a self-inspection program for sterile compounding.
• Implement changes to ensure compliance and complete Board of Pharmacy compliance checklists.
• Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness.
• Oversee compliance aspects of sterile compounding operations including aseptic technique and environmental controls.
• Assist in the review and approval of sterile compounding SOPs, documentation, and records.
• Monitor regulatory changes and assess operational impact.

Required qualifications

• 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>, <795> 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

About the company

Hims & Hers is a health and wellness platform that provides access to affordable, accessible, and personal healthcare. It is a public company traded on the NYSE.