503B Pharmacy Quality Manager

Role Summary

The Quality Manager oversees and maintains quality assurance (QA) and quality control (QC) programs in a 503B outsourcing facility. Responsibilities include ensuring compliance with FDA, cGMP, USP , USP , and DEA regulations, leading audits, managing investigations, and driving continuous improvement initiatives.

Job Activities and Responsibilities

• Ensure compliance with FDA 21 CFR Part 210 & 211, USP , USP , and cGMP requirements.
• Demonstrate proficiency and follow Standard Operating Procedures related to sterile compounding, cleanroom operations, and quality control.
• Develop and implement quality assurance procedures to ensure the quality of compounded medication.
• Supervise environmental monitoring (EM), sterility, endotoxin, and particulate testing to ensure product safety.
• Cook
• Coordinate internal audits, supplier audits, and regulatory inspections, responding to findings with appropriate action plans.
• Oversee QA/QC functions performed by compounding and quality personnel to ensure that procedures are followed and that all QA/QC tasks are properly documented.
• Work directly with Departmental Managers to assist with personnel training and compounding validations, including but not limited to scheduling, completing, and documenting all initial and ongoing Aseptic Process Simulations (APS), personnel skill assessments, didactic evaluations, and training plans.
• Oversee quality risk management, deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls.
• Work with Department Managers to evaluate patient complaints and adverse events, ensuring appropriate investigations and resolution.
• Oversee quality risk management, deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls.
• Oversee and maintain facility and equipment requirements, including but not limited to annual and biannual room certifications, monthly audits, equipment certifications, calibrations, and maintenance, and coordinate scheduling with Departmental Managers.
• Ensure proper validation of equipment, processes, and analytical methods used in production.
• Directly responsible for communication, documentation, and follow up with third-party laboratories regarding product testing, environmental sampling, and ongoing quality and stability study projects.
• Review and approve batch records, certificates of analysis (COAs), and release specifications.
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