Compliance Pharmacist, Sterile Compounding

The role

You will serve as the PIC Designee for sterile compounding at a 503A pharmacy. You will partner with the Pharmacist-in-Charge to ensure operations meet federal, state, and professional standards.

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.