Lead Compliance Pharmacist, Sterile Compounding & PIC Designee

K1 Industries; Mesa (AZ); On-site; USD 120,000 - 150,000; Full time

Job summary

Hims & Hers, a leading health and wellness platform, is seeking a Compliance Pharmacist specialized in sterile compounding for the 503A pharmacy. You will serve as the Designee for the 503A pharmacy, ensure licensure and regulatory adherence, and drive continuous quality improvements with the PIC and CQI teams.

You will design self-inspection programs, maintain SOPs, and monitor USP / compliance while coordinating audits and regulatory inquiries.

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

Documentation

Travel willingness

Education

Pharmacy degree (ACPE-accredited)

Tools

BCSCP certification

Job description

Hims & Hers, a leading health and wellness platform, is seeking a Compliance Pharmacist specialized in sterile compounding for the 503A pharmacy. You will serve as the Designee for the 503A pharmacy, ensure licensure and regulatory adherence, and drive continuous quality improvements with the PIC and CQI teams.

You will design self-inspection programs, maintain SOPs, and monitor USP / compliance while coordinating audits and regulatory inquiries.