Director of Medication Safety, Compliance and Quality

UTMB • Galveston, TX

9d

About The Position

Summary: The Medication Safety, Compliance and Quality Officer provides enterprise-wide leadership and subject matter expertise in medication safety, regulatory compliance, quality improvement, and accreditation readiness. This position ensures the safe, effective, and compliant use of medications across all practice settings - acute care, infusion, specialty pharmacy, ambulatory, and training programs - while advancing quality outcomes and operational excellence. The Officer develops and oversees medication safety and compliance programs, interprets and operationalizes regulatory requirements, and leads the organization's preparation for accreditation and inspections (The Joint Commission, CMS, DEA, FDA, state board, 340B, URAC, ACHC, ASHP Residency Accreditation). The role partners with leaders across pharmacy, nursing, medical staff, and administration to integrate safety, quality, and compliance principles into daily operations. Responsibilities: Develop, implement, and sustain medication safety policies, procedures, and best practices aligned with ASHP, ISMP, and national standards. Analyze and trend medication errors, adverse drug events, and near misses; conduct root cause analyses (RCA), failure mode and effects analyses (FMEA), and implement corrective actions. Champion a culture of safety and just culture, encouraging transparent reporting and system-based solutions. Lead and represent pharmacy services in multidisciplinary safety committees and integrate recommendations into practice. Ensure compliance with applicable laws, regulations, and accreditation standards (The Joint Commission, CMS Conditions of Participation, USP, DEA, FDA, state boards of pharmacy, 340B program rules). Maintain expertise in pharmacy accreditations across all service areas, including specialty pharmacy, infusion services, and pharmacy training programs, as well as applicable accrediting bodies and standards (e.g., The Joint Commission, URAC, ACHC, ASHP Residency Accreditation, PCAB, and other relevant entities). Lead internal audits, risk assessments, and readiness activities; develop and track corrective action plans. Serve as the primary liaison for regulatory surveyors and accreditation bodies. Design and execute enterprise-wide quality improvement initiatives across clinical, operational, and educational programs. Leverage data analytics to monitor safety and quality metrics, identify improvement opportunities, and report performance to leadership. Align quality initiatives with organizational goals and pharmacy’s strategic plan. Develop and deliver targeted education on safe medication practices, accreditation requirements, and quality improvement methods. Mentor leaders and frontline staff to integrate safety and compliance into daily workflows. Disseminate learnings from safety events and compliance reviews to drive continuous improvement. Partner with pharmacy leaders, clinicians, informatics, supply chain, and quality teams to ensure alignment of safety, compliance, and accreditation strategies across all services. Engage in system-level committees to influence enterprise policy and process design. Adheres to internal controls and reporting structure. Performs related duties as required.

Requirements

• Excellent communication and interpersonal skills with a high degree of professionalism and competence in dealing with a variety of professionals within various backgrounds.
• Comprehensive knowledge of medication-use systems, safety best practices, and accreditation standards for acute care, specialty, infusion, and training programs.
• Strong understanding of regulatory requirements (TJC, CMS, DEA, FDA, 340B, URAC, ACHC, ASHP Residency Accreditation).
• Expertise in safety science and quality improvement methodologies (RCA, FMEA, Lean, PDCA).
• Proven ability to lead complex, multi-site compliance and quality initiatives.
• Exceptional communication, leadership, and change management skills with a self-starter mindset.
• Ability to analyze complex data, interpret standards, and implement practical, sustainable solutions.
• Bachelor's degree in pharmacy plus six (6) years of related pharmacy experience to include three (3) years of related pharmacy management and supervisory experience with progressive responsibility.
• Licensed to practice pharmacy in the state of Texas or eligible for licensure from the Texas State Board of Pharmacy.
• Must be licensed with the Texas State Board of Pharmacy within 90 days of hire.

Nice To Haves

• PharmD.
• Advanced degree (M.S., MBA, or MHA).
• Completion of ASHP Medication Safety Certification or equivalent training.
• Prior experience leading regulatory/accreditation readiness.
• Management experience in a hospital-based or ambulatory pharmacy as appropriate.
• Leadership experience in acute care, specialty, and/or infusion settings; 340B program management experience.
• Demonstrated success in enterprise-level safety, compliance, and quality programs.
• Board certification through the Board of Pharmacy Specialties.

Responsibilities

• Develop, implement, and sustain medication safety policies, procedures, and best practices aligned with ASHP, ISMP, and national standards.
• Analyze and trend medication errors, adverse drug events, and near misses; conduct root cause analyses (RCA), failure mode and effects analyses (FMEA), and implement corrective actions.
• Champion a culture of safety and just culture, encouraging transparent reporting and system-based solutions.
• Lead and represent pharmacy services in multidisciplinary safety committees and integrate recommendations into practice.
• Ensure compliance with applicable laws, regulations, and accreditation standards (The Joint Commission, CMS Conditions of Participation, USP, DEA, FDA, state boards of pharmacy, 340B program rules).
• Maintain expertise in pharmacy accreditations across all service areas, including specialty pharmacy, infusion services, and pharmacy training programs, as well as applicable accrediting bodies and standards (e.g., The Joint Commission, URAC, ACHC, ASHP Residency Accreditation, PCAB, and other relevant entities).
• Lead internal audits, risk assessments, and readiness activities; develop and track corrective action plans.
• Serve as the primary liaison for regulatory surveyors and accreditation bodies.
• Design and execute enterprise-wide quality improvement initiatives across clinical, operational, and educational programs.
• Leverage data analytics to monitor safety and quality metrics, identify improvement opportunities, and report performance to leadership.
• Align quality initiatives with organizational goals and pharmacy’s strategic plan.
• Develop and deliver targeted education on safe medication practices, accreditation requirements, and quality improvement methods.
• Mentor leaders and frontline staff to integrate safety and compliance into daily workflows.
• Disseminate learnings from safety events and compliance reviews to drive continuous improvement.
• Partner with pharmacy leaders, clinicians, informatics, supply chain, and quality teams to ensure alignment of safety, compliance, and accreditation strategies across all services.
• Engage in system-level committees to influence enterprise policy and process design.
• Adheres to internal controls and reporting structure.
• Performs related duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager