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Hims & Hers, a leading telehealth and wellness platform (NYSE: HIMS), is seeking a Compliance Pharmacist for its 503A sterile compounding pharmacy in New Albany, Ohio. This is a critical regulatory and quality assurance role responsible for ensuring the highest levels of compliance with federal and state regulations governing sterile compounding operations.
You will serve as the Designee for the 503A pharmacy and act as a primary expert on all applicable state and federal regulations. Key responsibilities include:
- Serve as Designee for the 503A pharmacy in accordance with USP standards and applicable regulations, with backup PIC responsibilities as needed
- 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 to support continuous quality improvements
- Oversee compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality
- Review and approve 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
- 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 documented in line with regulatory standards
- 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
- Act as a member of the CQI Committee and facilitate continuous quality improvement processes
- Escalate significant compliance issues and trends to the PIC as appropriate
This role offers direct impact on patient safety and regulatory excellence while partnering with mission-driven teams in a fast-growing healthcare company.
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
- 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
