Pharmacy Director, Regulatory & Compliance; Mount Sinai Health System; Full Time; Days

About the role

The Director of Pharmacy Regulatory & Compliance provides strategic and operational leadership for regulatory readiness, accreditation compliance, medication-use safety, and controlled substance oversight across the Mount Sinai Health System enterprise pharmacy services.

Responsibilities

• Demonstrates executive leadership presence, professionalism, and accountability aligned with Mount Sinai Health System values and service standards.
• Serves as an enterprise pharmacy leader promoting a culture of patient safety, compliance, quality, collaboration, and continuous improvement.
• Demonstrates advanced knowledge of regulatory, accreditation, and compliance standards impacting health system pharmacy operations.
• Leads with a proactive and strategic approach to survey readiness and operational risk reduction.
• Demonstrates strong interdisciplinary partnership and change management capabilities across complex health system environments.
• Utilizes data analytics and operational metrics to drive regulatory performance improvement initiatives.
• Promotes innovation, operational efficiency, and standardization across enterprise pharmacy practices.

Enterprise Regulatory & Accreditation Leadership

• Provides enterprise-wide leadership and oversight for pharmacy regulatory compliance and accreditation readiness activities across all Mount Sinai Health System pharmacy locations.
• Leads and coordinates all pharmacy-related regulatory survey activities including TJC, CMS, NYSDOH, DEA, USP, Board of Pharmacy, and other regulatory or accrediting agencies.
• Develops and maintains an enterprise pharmacy regulatory readiness program to support continuous survey preparedness.
• Interprets, disseminates, and operationalizes new and revised regulatory requirements, standards, and guidance documents impacting pharmacy services.
• Serves as the pharmacy representative and subject matter expert during regulatory surveys, tracers, investigations, and corrective action planning.
• Collaborates with executive leadership to identify operational and regulatory risks and implement mitigation strategies.

Controlled Substance & Diversion Program Oversight

• Provides strategic oversight of the enterprise Drug Diversion Prevention Program.
• Oversees diversion monitoring technologies, workflows, investigations, reporting, and continuous improvement initiatives.
• PARTNERS WITH NURSING, SECURITY, COMPLIANCE, HUMAN RESOURCES, LEGAL, AND EMPLOYEE HEALTH ON DIVERSION PREVENTION, INVESTIGATION, AND RESPONSE ACTIVITIES.
• Ensures compliance with DEA, state, federal, and organizational controlled substance regulations and recordkeeping requirements.
• LEADS ENTERPRISE DIVERSION EDUCATION AND COMPETENCY PROGRAMS FOR PHARMACY AND INTERDISCIPLINARY STAFF.

Policy, Quality & Operational Compliance

• Oversees enterprise pharmacy policy and procedure governance, ensuring standardization, regulatory alignment, and operational applicability.
• Leads the development and execution of pharmacy compliance audit programs and quality assurance initiatives.
• Establishes enterprise compliance metrics, dashboards, and reporting mechanisms to monitor performance and identify opportunities for improvement.
• Collaborates with operational leaders to develop and implement corrective action plans resulting from audits, surveys, and identified compliance gaps.
• SUPPORTS AND ADVANCES MEDICATION-USE SAFETY INITIATIVES INCLUDING USP / COMPLIANCE, STERILE COMPOUNDING OVERSIGHT, HAZARDOUS DRUG HANDLING, AND ENVIRONMENTAL SAFETY PRACTICES.

Strategic & Operational Leadership

• Serves as a member of the Pharmacy Leadership Team and contributes to enterprise strategic planning initiatives.
• Leads interdisciplinary committees, workgroups, and operational initiatives related to pharmacy compliance, medication safety, and regulatory readiness.
• DRIVES STANDARDIZATION AND OPERATIONAL OPTIMIZATION ACROSS INPATIENT, AMBULATORY, INFUSION, SPECIALTY, AND PROCEDURAL PHARMACY SERVICES.
• PARTNERS WITH PHARMACY INFORMATICS AND OPERATIONAL TEAMS TO IMPROVE COMPLIANCE WORKFLOWS THROUGH TECHNOLOGY AND AUTOMATION SOLUTIONS.
• SUPPORTS SYSTEM INTEGRATION, OPERATIONAL TRANSFORMATION, AND STRATEGIC GROWTH INITIATIVES ACROSS THE ENTERPRISE.

Education, Training & Professional Development

• Develops and oversees enterprise regulatory education, competency validation, and compliance training programs.
• Provides mentorship and guidance to pharmacy leaders, managers, pharmacists, residents, technicians, and interdisciplinary staff.
• PRECEPTS PHARMACY STUDENTS AND RESIDENTS AS APPROPRIATE.
• Maintains professional expertise through continuing education, professional organizations, conferences, and regulatory engagement activities.

Additional Duties & Responsibilities

• LEADS MOCK TRACERS, READINESS ROUNDS, FOCUSED AUDITS, AND REGULATORY GAP ASSESSMENTS.
• COORDINATES REGULATORY DOCUMENTATION MANAGEMENT AND EVIDENCE PREPARATION FOR SURVEYS AND AUDITS.
• OVERSEES COMPETENCY TRACKING AND COMPLIANCE DOCUMENTATION FOR PHARMACY PERSONNEL ACROSS THE ENTERPRISE.
• PARTICIPATES IN ENTERPRISE QUALITY, SAFETY, AND OPERATIONAL IMPROVEMENT INITIATIVES.
• ASSISTS WITH BUSINESS CONTINUITY AND EMERGENCY PREPAREDNESS PLANNING RELATED TO PHARMACY REGULATORY OPERATIONS.
• PERFORMS OTHER DUTIES AS ASSIGNED BY PHARMACY EXECUTIVE LEADERSHIP.

Qualifications

• Bachelor of Science in Pharmacy or Doctor of Pharmacy (PharmD) degree from an accredited college of pharmacy.
• Current New York State Pharmacist License in good standing.
• Minimum of five (5) years of progressive hospital or health system pharmacy experience.
• Minimum of three (3) years of leadership, management, regulatory, quality, compliance, or operational oversight experience.
• Demonstrated experience with accreditation surveys, regulatory readiness, quality improvement, and policy development.
• Strong knowledge of CMS, TJC, DEA, USP /, NYSDOH, and Board of Pharmacy regulations.