Compliance Pharmacist, Sterile Compounding

hims-and-hers

Mesa (AZ)

On-site

USD 140,000 - 190,000

Full time

3 days ago
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Job summary

Hims & Hers is seeking a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for a 503A pharmacy in Mesa, AZ. You will lead regulatory compliance efforts, partner with PIC, and ensure USP and state board standards are met.

You will build and maintain self-inspection programs, support audits and inspections, manage licensure, and collaborate with quality and operations to drive patient safety and regulatory excellence.

Qualifications

  • Pharmacy degree from ACPE-accredited school.
  • BCSCP certification.
  • Active, unrestricted license in the practice state.
  • Willingness to obtain reciprocal licenses in other states.
  • Experience with sterile compounding, compliance, or quality roles.
  • Strong documentation and attention to detail.
  • Travel flexibility to support inspections and audits.

Responsibilities

  • Act as Designee for 503A pharmacy per regulations and USP.
  • Maintain active state licensure and backup PIC responsibilities.
  • Lead CQI activities and SOP alignment.
  • Ensure USP/state board compliance and internal policies.
  • Design and execute sterile compounding self-inspections.
  • Support PIC license, registrations, regulatory readiness.
  • Oversee aseptic technique, environmental controls, cleaning.
  • Review and approve sterile compounding SOPs and records.
  • Monitor regulatory changes and implement updates.
  • Support training and competency programs.
  • Assist investigations and CAPA development.
  • Prepare for inspections and audits.
  • Document training programs and competency.
  • Collaborate with operations, quality, leadership to manage risks.
  • Escalate significant compliance issues.

Skills

Sterile compounding
Regulatory compliance
Documentation & recordkeeping
Travel willingness
Audit & inspections support

Education

ACPE-accredited PharmD
BCSCP certification
Active pharmacist license
Eligibility for reciprocal licenses

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 .

Compliance Pharmacist, Sterile Compounding (503A)

About the Role

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

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
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

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