Compliance Pharmacist, Sterile Compounding

Hims & Hers•New Albany, OH

4d•$1 - $1

About The Position

The Compliance Pharmacist is responsible for regulatory adherence and quality assurance within the 503A sterile compounding pharmacy. The role serves as the primary expert on applicable state and federal regulations and drives a culture of continuous compliance and quality excellence. It acts as the Designee for the 503A pharmacy in the appropriate functional area, supports the PIC, and helps ensure the pharmacy is inspection-ready and operating in accordance with applicable regulations, USP standards, and internal policies. The role oversees compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection, in partnership with Quality. It supports self-inspections, continuous quality improvement, SOP and record review, regulatory change implementation, personnel qualification and competency programs, investigations and CAPA, and preparation for regulatory inspections and audits. The Compliance Pharmacist collaborates with pharmacy operations, quality, and leadership to manage risks and escalates significant issues to the PIC as appropriate.

Requirements

Five 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 and strong documentation and organizational skills.
Ability to translate regulatory requirements into practical, scalable processes.
Willingness to travel.

Nice To Haves

Prior experience serving as a Designated Person (DP) or PIC Designee.
Experience in high-growth or regulated healthcare environments.
Background working with cross-functional teams, including quality and legal.
Advanced training or certification in sterile compounding or pharmacy quality.

Responsibilities

Act as the Designee for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area.
Maintain active pharmacist licensure in applicable jurisdictions and fulfill backup PIC responsibilities as needed.
Serve as a member of the CQI Committee and 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 sterile compounding self-inspection program to support continuous quality improvement.
Implement compliance changes and complete Board of Pharmacy compliance checklists as applicable.
Support the PIC in maintaining pharmacy licensure, registrations, 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 reviewing and approving sterile compounding SOPs, documentation, and records for regulatory alignment.
Monitor regulatory changes, assess their operational impact, and 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 align with regulatory standards and are appropriately documented.
Track and ensure timely resolution of inspection findings and audit observations.
Partner with pharmacy operations, quality, and leadership to proactively manage compliance risks.
Escalate significant compliance issues and trends to the PIC as appropriate.