Description
Job Description
As a Compliance Pharmacist, Sterile Compounding at Hims & Hers, you will play a critical role in ensuring regulatory adherence and quality assurance within the 503A sterile compounding pharmacy.
Key Responsibilities
- 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 as needed.
- Facilitate the CQI process according to the SOP.
- Ensure ongoing compliance with USP <797> and <800>, 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.
- Assist in the review and approval of sterile compounding SOPs, documentation, and records.
- Monitor regulatory changes and assess operational impact.
- Support environmental monitoring, personnel qualification, media fills, and competency programs.
- Participate in investigations, root cause analyses, and CAPA development.
- Prepare for and support state board inspections, internal audits, and third-party assessments.
- Ensure training programs and competencies are in line with regulatory standards.
- Track and ensure timely resolution of inspection findings and audit observations.
- Partner cross-functionally to proactively manage compliance risks.
- Escalate significant compliance issues and trends to the PIC.
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.
- Experience supporting audits, inspections, or regulatory inquiries.
- Excellent attention to detail with strong documentation and organizational skills.
- Ability to translate regulatory requirements into practical 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.
- Advanced training or certification in sterile compounding or pharmacy quality.
Why You'll Love Working at Hims & Hers
- Direct impact on patient safety and regulatory excellence.
- Partnership with smart, mission-driven teams.
- Opportunity to scale compliant, high-quality pharmacy operations.