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The Sterile Pharmacy Operations Manager is responsible for the leadership, coordination, and operational oversight of the sterile compounding department. This role ensures daily workflow efficiency, robust regulatory compliance, quality standards, and the continuous development of the sterile team. Serving as both a strategic leader and hands-on operational manager, the Sterile Pharmacy Operations Manager oversees technician task allocation, training programs, prescription and batch verification, quality assurance practices, and sterile production readiness. The Manager fosters a culture of safety, accountability, and excellence while ensuring all compounding activities meet USP <797>, cGMP, and company standards.
Job Responsibility:
Provide daily leadership, supervision, training and performance management for the sterile compounding team
Assign compounding and preparation tasks based on technician skillset, training progress, performance history, and workflow needs
Support staffing and scheduling decisions, including shift planning, hood rotation schedules, and daily workload distribution
Oversee daily sterile production workflows to ensure efficiency, compliance, and on-time completion of critical lots
Manage and support “outside-the-hood” duties including equipment preparation, autoclaving, oven operations, cleanroom resupply, labeling tasks, and end-of-day organization
Ensure all facility and equipment readiness requirements are met, including cleanliness, maintenance, calibration, and required documentation
Verify patient-specific prescriptions, compounded lots, and batch records, ensuring accuracy, completeness, and adherence to SOPs
Perform or oversee required pharmacy calculations and validate ingredient measurements for potency and accuracy
Ensure strict adherence to USP <797>, USP <795>, USP <800>, 503B guidance, 21 CFR 211 (cGMP), and all applicable state and federal regulations
Maintain policies related to aseptic technique, gowning, environmental controls, and cleanroom behavior
Conduct and participate in audits, environmental monitoring review, and regulatory inspections
Support periodic review and updates of sterile compounding SOPs, ensuring alignment with regulatory standards and best practices
Partner with QA, Supply Chain, Pharmacy Leadership, and other departments to optimize workflow and ensure regulatory compliance
Requirements:
Bachelor of Science (BS) in Pharmacy, Doctor of Pharmacy (PharmD)