Lead Pharmacist, Pharmacy Compliance

OpenLoop Health•Stockton, CA

10d•Onsite

About The Position

OpenLoop is seeking a Lead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at its licensed compounding facility. The role owns execution of USP <795>, <797>, and <800> programs, maintains inspection readiness, and serves as the primary compliance interface between the site and centralized pharmacy leadership. The position reports directly to the corporate compliance leadership team. The Lead Pharmacist oversees site compliance and quality systems, including environmental monitoring, personnel training and competency, SOP management, CAPA, facility qualification records, hazardous-drug controls, compounding documentation, material review, supplier qualification, inspections, product complaints, adverse-event reporting, and recalls. They work independently to manage competing compliance obligations and communicate operational requirements to staff while escalating issues to leadership.

Requirements

B.S. in Pharmacy or Pharm.D. from an ACPE-accredited institution.
Active, unrestricted pharmacist license in the state of practice.
At least 3 years of experience 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 environmental monitoring programs, deviation management, or CAPA systems.
Practical command of USP <795>, <797>, and <800> (2023), including environmental monitoring programs, competency requirements, and quality systems.
Experience with deviation investigations, CAPA, and environmental monitoring data analysis.
Disciplined documentation, risk-based thinking, and the ability to manage competing compliance obligations without close oversight.
Collaborative communication skills, including translating regulatory requirements into clear operational direction for staff and escalating clearly to leadership.

Nice To Haves

Additional state pharmacist licensure.
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 the compounding regulatory landscape.

Responsibilities

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