Lead Sterile Compounding Compliance Pharmacist

Hims & Hers; New Albany (OH); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Hims & Hers is seeking a Compliance Pharmacist to lead regulatory adherence for a 503A sterile compounding pharmacy. You will ensure licensure, manage CQI, and drive compliance with USP <797>/<800> and state boards. The role requires licensure in practice states and prior sterile compounding/exposure to regulatory inquiries.

The position emphasizes quality assurance, documentation, and cross‑functional collaboration to uphold patient safety and regulatory excellence across the organization.

Qualifications

• Pharmacy degree from an ACPE-accredited school of pharmacy.
• Active, unrestricted Pharmacist license in the state of practice.
• 5 years of sterile compounding experience.
• Board Certified Sterile Compounding Pharmacist (BCSCP) certification.
• Willingness to obtain reciprocal licenses in other states.
• Experience in sterile compounding, pharmacy compliance, or quality roles.
• Strong knowledge of USP <797>, <800>, and state board regulations for 503A pharmacies.
• Experience supporting audits, inspections, or regulatory inquiries.
• Attention to detail with strong documentation and organizational skills.
• Ability to translate regulatory requirements into practical, scalable processes.
• Willingness to travel.

Responsibilities

• Act as the Designee for the 503A pharmacy per regulations and USP in the relevant area.
• Ensure active state pharmacist licensure and fulfill backup PIC responsibilities.
• Facilitate the CQI process and oversee self-inspection programs for sterile compounding.
• Maintain compliance with USP <797> and <800>, state boards, and internal policies.
• Support PIC in licensure, registrations, and regulatory readiness.
• Oversee sterile compounding compliance, including aseptic technique and environmental controls.
• Review and approve sterile compounding SOPs, documentation, and records.
• Monitor regulatory changes and implement updates with stakeholders.
• Support environmental monitoring, training, and CAPA activities.
• Participate in investigations, root cause analyses, and audits.
• Prepare for inspections and audits; document training and competencies.
• Escalate compliance issues to the PIC and collaborate cross-functionally.

Skills

Sterile compounding

Regulatory compliance

GMP/Quality systems

Audits/inspections

Pharmacy operations

Documentation

Willingness to travel

Education

Doctor of Pharmacy (PharmD)

ACPE-accredited school

Active pharmacist license in state of practice

Board Certified Sterile Compounding Pharmacist (BCSCP)

Job description

Hims & Hers is seeking a Compliance Pharmacist to lead regulatory adherence for a 503A sterile compounding pharmacy. You will ensure licensure, manage CQI, and drive compliance with USP <797>/<800> and state boards. The role requires licensure in practice states and prior sterile compounding/exposure to regulatory inquiries.

The position emphasizes quality assurance, documentation, and cross‑functional collaboration to uphold patient safety and regulatory excellence across the organization.