Lead Pharmacist, Pharmacy Compliance

Alt; Stockton (CA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision plans

Flexible PTO

401(k) + Company Match

Life Insurance

HSA/FSAs

Job summary

California Quality Pharmacy, a Stockton, CA sterile compounding facility, seeks a Lead Pharmacist, Pharmacy Compliance to own USP <795>, <797>, and <800> programs and maintain inspection readiness. You will coordinate CAPA, environmental monitoring, SOPs, and training, interfacing with centralized leadership.

The role requires strong regulatory expertise, 503A experience, and a hands-on approach to ensure continuous compliance and quality across operations.

Qualifications

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from ACPE-accredited institution.
• 3+ years in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility.
• Working knowledge of USP <795>, <797>, and <800> (2023).
• Hands-on experience with EM programs, deviation management, or CAPA systems.

Responsibilities

• Own day-to-day USP <795>, <797>, <800> compliance — keep operations, controls, personnel practices, and quality systems audit-ready.
• Manage environmental monitoring program: viable air/surface sampling and parameter tracking.
• Maintain SOP library — draft, update, version-control, train personnel on procedures.
• Lead personnel training and competency program per USP <797> Section 7.
• Own the site CAPA program — deviation documentation, root cause analysis, corrective actions, closure.

Skills

USP compliance

Regulatory knowledge

Documentation

CAPA & deviations

Training & coaching

Education

B.S. in Pharmacy or Pharm.D. (ACPE-accredited)

Tools

EM programs

CAPA systems

Job description

About the Role

California Quality Pharmacy is looking for a Lead Pharmacist, Pharmacy Compliance to serve as the on‑site compliance authority at its licensed compounding facility — owning USP <795>, <797>, and <800> program execution, maintaining inspection readiness, and acting as the primary compliance interface between the site and centralized pharmacy leadership. This role reports directly to the corporate compliance leadership team.

What You'll Do

• Own day‑to‑day USP <795>, <797>, and <800> (2023) compliance — keeping operations, controls, personnel practices, and quality systems current, documented, and audit‑ready.
• Manage the environmental monitoring program: viable air and surface sampling, non‑viable particle and pressure/temperature/humidity tracking, action level investigation, and CAPA.
• Maintain the SOP library — draft, update, version‑control, and train personnel on all compliance‑related procedures.
• Run the personnel training and competency program per USP <797> Section 7: initial and ongoing assessments, media fill, gloved fingertip sampling, garbing, and remediation.
• Own the site CAPA program — deviation documentation, root cause analysis, corrective action tracking to verified closure, and trend reporting to leadership.
• Maintain facility qualification records: ISO certification schedules, equipment re‑qualification triggers, and calibration documentation.
• Coordinate USP <800> compliance: engineering controls, PPE protocols, Assessment of Risk, and spill response readiness.
• Oversee MFR/CR completeness, BUD documentation, incoming material/COA review, and supplier qualification records.
• Conduct mock inspections and gap assessments; support response to state board, FDA, or accreditation survey findings.
• Manage product complaints, adverse event reporting, and site‑level recall procedures.
• Other duties as assigned.

Who You Are

• B.S. in Pharmacy or Pharm.D. from an ACPE‑accredited institution with an active, unrestricted pharmacist license in the state of practice.
• Additional state pharmacist licensure is beneficial, but not required
• 3+ years of hands‑on experience in sterile compounding operations or pharmaceutical QA at a licensed 503A facility or 5+ years in pharmaceutical quality/compliance without direct 503A experience, with commitment to complete USP training in 90 days.
• Practical command of USP <795>, <797> and <800> (2023) — EM programs, competency requirements, and quality systems.
• Experience with deviation investigations, CAPA, and environmental monitoring data analysis.
• Disciplined documenter, risk‑based thinker, and self‑directed — able to manage competing compliance obligations without close oversight.
• Collaborative communicator who can translate regulatory requirements into clear operational direction for staff and elevate clearly to leadership.

Required Qualifications

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from an ACPE‑accredited institution.
• 3+ years in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility.
• Working knowledge of USP <795>, <797> and <800> (2023).
• Hands‑on experience with EM programs, deviation management, or CAPA systems.

Preferred Qualifications

• Experience at a state‑licensed 503A sterile compounding pharmacy.
• Familiarity with state board inspection processes and sterile compounding enforcement.
• ISO 5/7/8 cleanroom classification and NABP/PCAB accreditation experience.
• Experience responding to inspection observations, FDA Form 483s, or voluntary disclosures.
• Familiarity with compounding regulatory landscape.

Our Benefits

In addition, for salaried positions you would also be eligible for:

• Medical, Dental, and Vision plans
• Flexible Spending/Health Savings Accounts
• Flexible PTO
• 401(k) + Company Match
• Life Insurance, Pet insurance, and more

Join California Quality Pharmacy, a growing 503A sterile compounding pharmacy based in Stockton, California. We specialize in sterile pharmaceutical compounding, delivering high‑quality, patient‑specific medications with a strong commitment to regulatory compliance and clinical excellence. As we continue to expand, we’re looking for dedicated professionals who take pride in precision and patient care.