Senior Compliance Pharmacist — Sterile Compounding

hims-and-hers; New Albany (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Hims & Hers is seeking a Compliance Pharmacist to serve as the 503A Designee, maintaining licensure and ensuring strict adherence to USP and state board requirements. You will drive quality programs, perform self-inspections, and lead regulatory readiness across sterile operations.

You will collaborate with Pharmacy, Quality, and Operations to implement compliant processes, manage audits, and support ongoing education while traveling as needed.

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, 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.

Responsibilities

• Act as the Designee for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area.
• Ensure active state pharmacist licensure in applicable jurisdictions and fulfill backup PIC responsibilities as needed.
• Act as a member of the CQI Committee, facilitate the CQI process according to the SOP.
• Ensure ongoing compliance with USP and state board requirements and internal policies.
• Design, execute and maintain a self-inspection program for sterile compounding to support continuous quality improvements.
• Implement changes to ensure compliance and complete Board of Pharmacy checklists as applicable.
• Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness and recordkeeping.
• 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 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 with training and quality departments.
• 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 in line with regulatory standards and documented.
• 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.
• Escalate significant compliance issues and trends to the PIC as appropriate.

Skills

Sterile compounding

Regulatory compliance

Quality assurance

Documentation

Willingness to travel

Education

Pharmacy degree (ACPE-accredited)

Job description

Hims & Hers is seeking a Compliance Pharmacist to serve as the 503A Designee, maintaining licensure and ensuring strict adherence to USP and state board requirements. You will drive quality programs, perform self-inspections, and lead regulatory readiness across sterile operations.

You will collaborate with Pharmacy, Quality, and Operations to implement compliant processes, manage audits, and support ongoing education while traveling as needed.