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Compliance Pharmacist, Sterile Compounding

Hims & Hers
New Albany, USA
Full-time
Mid
Onsite
$1 / year
Discovered 6 days ago

Full Job Posting

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 <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

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 <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

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. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
  • Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
  • It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
  • Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.
  • To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

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. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

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