Senior Manager, Compounding and Quality Operations

Our client is looking for someone with strong long-term potential who can develop into a Plant Manager one day. This role will have a primary focus on compounding operations and offers the opportunity to grow within a stable, expanding pharmaceutical organization.Responsibilities Provides leadership, oversight and management of Manufacturing Quality, Compounding personnel and activities within the Manufacturing plantSupports continuous improvement with emphasis on manufacturing quality systems and processesEnsures that manufacturing processes, facilities, and operations comply with FDA, cGMP, and internal quality standards and procedures Works closely with Quality Assurance, Quality Control, Plant Scheduling and Maintenance/Engineering to maintain consistent product quality and complianceComprehensive understanding of cGMP regulations as applied to pharmaceutical manufacturing operationsResponsible for overseeing that Compounding personnel are properly trained and carefully execute manufacturing processes (SOP’s, Batch Records) GMPs, equipment, systems, and safetyResponsible for making recommendations for new equipment and/or the modification of existing equipment and/or systems as is necessary or appropriate Responsible for cooperating with all Operations Management to assure that all resources and equipment in the Compounding area are properly maintained and repaired to assure validity, efficiency and safety of manufacturing processesFacilitate, promote, and direct timely changes in manufacturing as mandated by ManagementStrong investigation and report writing skills with ability to review and assess manufacturing deviations, change controls, and CAPA effectivenessDemonstrated ability to manage quality assurance compliance for manufacturing areas, including batch record review, line clearance, and in-process inspectionsResponsible for overseeing the corporation's compounding operations with primary emphasis on manufacturing quality and effectively maximize productivity from facilities, equipment, and human resources and to comply with all relevant regulationsResponsible for overseeing that Compounding personnel are properly trained and carefully execute manufacturing processes (SOP’s, Batch Records) GMPs, equipment, systems, and safetyProvide manufacturing quality and compounding operations oversight for all related manufacturing operations, ensuring adherence to cGMPs and internal proceduresEXPERIENCE Required: 6–8 years of progressive experience in pharmaceutical compounding, manufacturing including Quality Assurance or Quality Systems experiencePreferred: 3–5 years of leadership or supervisory experience in a GMP-regulated manufacturing quality environment. Solid-dose manufacturing and Quality Assurance experience preferred.