Jobs · Healthcare · Ohio

Compliance Pharmacist, Sterile and Non-Sterile Compounding

hims & hers · New Albany, OH · 1 wk ago
On-siteHealthcareFull-time

About the role

Hims & Hers is seeking a Compliance Pharmacist with extensive sterile and nonsterile compounding expertise to serve as the Designated Person (DP) for compounding at our 503A pharmacy. This role involves partnering with the Pharmacist-in-Charge (PIC) to ensure compliance with BOP rules and regulations, USP chapters, and state board of pharmacy requirements. The Compliance Pharmacist will oversee sterile compounding operations, support audits, and assist in investigations.

Responsibilities

  • Act as a Pharmacist designee for the PIC, ensuring compliance with BOP rules and regulations and applicable USP chapters for the corresponding 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, facilitating the CQI process according to the SOP.
  • 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.
  • Oversee compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality.
  • Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness and record keeping.
  • Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness and record keeping.
  • Oversee compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality.
  • 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.

Requirements

  • 2 years of Sterile compounding experience.
  • Pharmacy degree from an ACPE-accredited school of pharmacy.
  • Active, unrestricted Pharmacist license in the state of practice.
  • 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.
  • Excellent attention to detail with strong documentation and organizational skills.
  • Ability to translate regulatory requirements into practical, scalable processes.
  • Willingness to travel to sister sites as needed for training.

Qualifications

  • Experience supporting audits, inspections, or regulatory inquiries.
  • Board Certified Sterile Compounding Pharmacist (BCSCP) certification (nice to have).
  • Advanced training or certification in compounding or pharmacy quality.
  • Experience in high-growth or regulated healthcare environments.
  • Experience in pharmacy accreditation programs (VPP, ACHC, PCAB) (nice to have).

Skills

  • Strong understanding of regulatory requirements and ability to translate them into practical processes.
  • Effective communication and collaboration skills.
  • Attention to detail and strong organizational skills.
  • Ability to work independently and as part of a team.

Benefits

  • Competitive salary & equity compensation for full-time roles.
  • Unlimited PTO, company holidays, and quarterly mental health days.
  • Comprehensive health benefits including medical, dental & vision, and parental leave.
  • Employee Stock Purchase Program (ESPP).
  • 401k benefits with employer matching contribution.
  • Offsite team retreats.

Similar jobs