Director of Pharmacy Operations

Summary The Director of Pharmacy Operations is responsible for strategic leadership and oversight of pharmacy operations, ensuring safe, compliant, and efficient production of compounded sterile and non-sterile medications in accordance with FDA 503B outsourcing facility requirements, USP <797>/<800>, cGMP, and applicable state and federal regulations. This role includes managing personnel, workflow, regulatory compliance, and cross-functional collaboration to drive operational excellence while ensuring patient safety and regulatory adherence. Essential Duties and Responsibilities · Collaborate with the PIC to provide operational leadership to pharmacists, pharmacy managers, technicians, and support staff across all areas of sterile compounding and pharmacy operations. · Oversee production planning, workflow management, and execution of schedules to ensure on-time delivery of medications to clients. · Ensure compliance with company SOPs, FDA 21 CFR Part 210/211, DEA requirements, USP standards, and state/federal regulations. · Serve as an operational liaison to Quality Assurance, Document Control, and Regulatory Affairs. · Implement, monitor, and maintain quality management processes including CAPA, root cause analysis, deviation investigations, and product impact assessments. · Direct oversight of cleanroom operations, including environmental monitoring, aseptic technique compliance, and cleaning validation adherence. · Assist with internal audits and support external inspections (FDA, DEA, State Boards of Pharmacy). · Mentor, train, and evaluate staff; conduct performance reviews; collaborate with the PIC to develop succession planning for pharmacy operations leadership roles. · Manage controlled substance receipt, storage, accountability, and reconciliation in compliance with DEA and state regulations. · Ensure proper reconciliation and verification of all labeling, including primary and tertiary labels, and supervise corrective actions when discrepancies occur. · Collaborate with procurement and warehouse teams to maintain sufficient raw material and finished goods inventory. · Participate in continuous quality improvement initiatives and lead operational projects such as new product launches, workflow redesign, and system implementations. · Collaborate with the PIC to coordinate licensure activities to support business expansion into additional states. Qualifications To perform this role successfully, an individual must demonstrate strong leadership, organizational, and regulatory knowledge. Education and Experience · Doctor of Pharmacy (PharmD) from an accredited College of Pharmacy. · Minimum of five (5) years of progressive leadership experience in sterile compounding or outsourcing facility operations. · Demonstrated knowledge of cGMP, USP <797>/<800>, and 503B outsourcing facility requirements. · Proven experience managing cross-functional teams and regulatory inspections. Certificates, Licenses, Registrations · Active pharmacist license in Texas. · Must obtain and maintain pharmacist licensure in multiple additional states (company-sponsored, including exam costs, travel, and annual renewal). · Eligibility for licensure in designated states required within six (6) months of hire. Skills and Competencies · Strong leadership, communication, and interpersonal skills to manage diverse teams and external stakeholders. · Ability to analyze operational metrics and implement process improvements. · Proficiency in documentation control, batch record review, and deviation investigations. · Strong problem-solving and decision-making skills with the ability to manage competing priorities. Job Type: Full-time Pay: From $150,000.00 per year Benefits: • 401(k) • 401(k) matching • Dental insurance • Employee assistance program • Flexible spending account • Health insurance • Life insurance • Paid time off • Vision insurance Application Question(s): • Do you have A Minimum of five (5) years of progressive leadership experience in sterile compounding or outsourcing facility operations? • Do youhave knowledge of cGMP, USP <797>/<800>, and 503B outsourcing facility requirements? • Do you have proven experience managing cross-functional teams and regulatory inspections? • Are you a ble to comply with wligibility for licensure in designated states required within six (6) months of hire? Work Location: In person