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 orting 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.

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.

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…