Lead Compliance Pharmacist, Sterile Compounding (503A)

Hims & Hers; Mesa (AZ); On-site; USD 140,000 - 190,000; Full time

Job summary

Hims & Hers is seeking a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for our 503A pharmacy. In this role you’ll partner with the Pharmacist-in-Charge (PIC) to ensure sterile compounding operations meet federal, state, and professional standards, maintaining a culture of compliance, quality, and patient safety as we scale.

You will lead self-inspections, ensure USP 797/800 compliance where applicable, support audits, inspections, CAPA, and regulatory

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>, <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

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 <797> and <800> (as applicable), state board of pharmacy 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 compliance 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, environmental controls, cleaning, and disinfection in partnership with Quality.
• 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 in partnership 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 appropriately 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

Audits & inspections

Documentation & recordkeeping

Travel readiness

Education

Pharmacy degree (ACPE-accredited)

BCSCP certification

Job description

Hims & Hers is seeking a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for our 503A pharmacy. In this role you’ll partner with the Pharmacist-in-Charge (PIC) to ensure sterile compounding operations meet federal, state, and professional standards, maintaining a culture of compliance, quality, and patient safety as we scale.

You will lead self-inspections, ensure USP 797/800 compliance where applicable, support audits, inspections, CAPA, and regulatory