Lead Pharmacist, Pharmacy Compliance

Location: Stockton, California, United States; work is on-site at a licensed compounding facility.

Company

hirify.global provides telehealth support solutions that help companies deliver virtual care across all 50 states. California Quality Pharmacy is a growing 503A sterile compounding pharmacy focused on patient-specific medications, regulatory compliance, and clinical excellence.

What you will do

• Own day-to-day USP <795>, <797>, and <800> compliance, ensuring operations, personnel practices, controls, and quality systems remain documented and audit-ready.
• Manage environmental monitoring, including viable and non-viable sampling, facility condition tracking, action-level investigations, and CAPA.
• Maintain the SOP library and lead personnel training and competency activities, including media fills, gloved fingertip sampling, garbing, assessments, and remediation.
• Own deviation documentation, root cause analysis, corrective action tracking, trend reporting, and verified CAPA closure.
• Maintain facility qualification, equipment re-qualification, calibration, MFR/CR, BUD, COA, and supplier qualification records.
• Conduct mock inspections, gap assessments, complaint and adverse event handling, recall procedures, and responses to state board, FDA, or accreditation findings.

Requirements

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from an ACPE-accredited institution.
• 3+ years of experience in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility; alternatively, 5+ years in pharmaceutical quality or compliance without direct 503A experience, with USP training completed within 90 days.
• Working knowledge of USP <795>, <797>, and <800> (2023), including environmental monitoring, competency requirements, and quality systems.
• Hands-on experience with environmental monitoring programs, deviation management, CAPA systems, or related quality investigations.
• Ability to document precisely, assess risk, work independently, communicate operational requirements clearly, and escalate issues to leadership.

Nice to have

• Experience in a state-licensed 503A sterile compounding pharmacy.
• Familiarity with state board inspections, sterile compounding enforcement, FDA Form 483 responses, or voluntary disclosures.
• ISO 5/7/8 cleanroom classification and NABP/PCAB accreditation experience.
• Additional state pharmacist licensure.

Culture & Benefits

• Medical, dental, and vision plans.
• Flexible Spending Accounts and Health Savings Accounts.
• Flexible paid time off.
• 401(k) with company match.
• Life insurance, pet insurance, and additional benefits.
• Flat organizational structure with an emphasis on autonomy, competence, belonging, and employee-driven ideas.