Director of Pharmacy Operations

Summary Apex Pharmacy Solutions, a Texas-licensed 503A Class Sterile Compounding Pharmacy headquartered in Spring, Texas, specializes in wellness optimization, peptide therapy, longevity medicine, and performance-based medicine. The Director of Operations is a senior leadership role responsible for directing both sterile and non-sterile compounding operations across the organization. This position drives optimization of compounding workflows, scaling of production capacity, regulatory-compliant batch output, maintenance of aseptic conditions, and development of a high-performance compounding team. The ideal candidate brings deep expertise in pharmaceutical compounding, fluent command of USP and USP standards, and a demonstrated track record in pharmacy operations management at scale. Reporting to the Chief Operating Officer (COO), the Director of Operations partners cross-functionally with the Pharmacist-in-Charge, Quality Assurance, Procurement & Warehouse, and executive leadership to advance Apex's operational excellence, regulatory standing, and growth. Responsibilities Production Management Provide strategic leadership to sterile and non-sterile compounding teams, upholding the highest standards of safety, efficiency, and product quality. Drive production schedule adherence and resource allocation to meet prescription demand, turnaround times, and patient delivery SLAs. Own batch record execution, in-process controls, and production KPIs including throughput, yield, cycle time, and labor productivity. Identify and eliminate bottlenecks across production workflows to scale capacity while maintaining compliance and safety standards. Establish, implement, and continuously improve Standard Operating Procedures (SOPs) for compounding, cleaning, and environmental monitoring. Process Engineering & Scale-Up Ensure continuous compliance with applicable federal and state regulations, including USP , USP , Texas State Board of Pharmacy (TSBP) requirements, and FDA guidance applicable to 503A pharmacies. Lead the development, validation, and continuous improvement of compounding processes, ensuring reproducibility, efficiency, and regulatory alignment. Partner with compounding and clinical staff to transition pilot formulations into scalable, production-ready processes. Oversee equipment qualification (IQ/OQ/PQ) and capacity planning for new production lines, cleanroom expansions, and automation integration. Facility & Cleanroom Oversight Maintain full operational control of sterile compounding suites, ensuring adherence to ISO classification standards and environmental control requirements. Enforce gowning, cleaning, disinfection, and aseptic technique standards in accordance with USP . Direct facility readiness for regulatory audits, planned shutdowns, and preventive maintenance cycles. Drive innovation in formulations, process optimization, and operational scalability while preserving patient-specific customization standards. Regulatory & Manufacturing Compliance Ensure all production activities comply with 503A regulatory requirements, USP and USP guidelines, and applicable NABP and TSBP standards. Direct the preparation and accuracy of batch production records, compounding logs, and cleaning validation documentation. Partner with Quality Assurance and Quality Control on product release testing, deviation investigations, corrective and preventive actions (CAPA), and documentation audits. Workforce Development Recruit, hire, train, and lead a high-performing team of compounding technicians, production supervisors, and support staff across all shifts. Set clear performance goals and mentor team members on aseptic technique, operational efficiency, and GMP mindset. Foster a culture of safety, accountability, and pride in production excellence. Requirements Education Bachelor's degree in Business Administration, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific field required. MBA, MHA, or equivalent advanced degree strongly preferred. Experience Minimum seven years of experience in pharmaceutical compounding, manufacturing operations, or pharmacy business operations, including at least three years in a senior leadership capacity. Prior experience within a 503A or 503B compounding pharmacy facility strongly preferred. Demonstrated track record managing sterile and non-sterile drug production in compliance with USP and state board standards. Direct experience leading large-scale batch production and cleanroom operations. Technical Skills In-depth working command of USP , USP standards, FDA 503A guidance, and Texas State Board of Pharmacy regulations. Familiarity with Lean, Six Sigma, or comparable continuous improvement methodologies. Experience with automation, robotics, or high-throughput compounding systems. Proficiency with pharmacy production software platforms such as Pioneer, Pestle, or equivalent. Experience leading or supporting facility expansion, including scaling operations, equipment relocation, and maintaining compliance throughout transitions. Professional Competencies Demonstrated strategic leadership balanced with operational discipline and tactical execution. Strong financial acumen with the ability to manage departmental budgets, analyze cost drivers, and build the business case for capital investments. Proven capability to build, develop, and retain high-performing operational teams across multiple shifts. Effective executive communicator able to interact professionally with internal teams, regulatory personnel, and senior leadership. High degree of integrity and discretion in handling sensitive pharmaceutical, financial, and proprietary information. Physical Requirements Extended periods of standing, walking, and movement throughout the production floor and cleanroom suites. Capacity to wear required PPE and sterile garbing for extended durations. Ability to lift and transport up to 25 pounds. Manual dexterity sufficient to operate compounding equipment, computer systems, and standard production tools. Work Environment Onsite, in-person role at the Apex facility in Spring, Texas. Pharmacy production and ISO-classified cleanroom environment within a Texas-licensed 503A Class Sterile Compounding Pharmacy. Routine presence on the production floor; required adherence to gowning, PPE, hygiene, and access-control protocols. Occasional extended hours during high-volume production cycles, regulatory inspections, audits, or facility transitions. #J-18808-Ljbffr Apex Pharmacy Solutions