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 the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals .

You Will

• 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 (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

This critical role is responsible for ensuring the highest levels of regulatory adherence and quality assurance within the 503A sterile compounding pharmacy. The Compliance Pharmacist will serve as the primary expert on all applicable state and federal regulations, driving a culture of continuous compliance and quality excellence.

You Have

• 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

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

Why You'll Love Working at Hims & Hers

• You'll have a direct impact on patient safety and regulatory excellence
• You'll partner with smart, mission-driven teams across pharmacy and operations
• You'll help scale compliant, high-quality pharmacy operations in a fast-growing healthcare company
• We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Lo