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

Mount Sinai Health System•New York, NY

2d•Onsite

About The Position

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. This leader is responsible for developing, implementing, and sustaining a comprehensive pharmacy regulatory and compliance program that ensures ongoing readiness for all federal, state, and accreditation standards, including but not limited to CMS, The Joint Commission (TJC), NYSDOH, DEA, USP <797>/<800>, and other applicable regulatory agencies. The role serves as the enterprise pharmacy subject matter expert for regulatory and accreditation matters and partners collaboratively with pharmacy, nursing, medical staff, quality, compliance, legal, supply chain, informatics, and operational leadership to advance a culture of safety, accountability, standardization, and continuous survey readiness across the health system. The Director functions as a strategic leader responsible for driving enterprise-wide initiatives related to medication-use compliance, diversion prevention, quality improvement, operational standardization, policy governance, and regulatory risk mitigation.

Requirements

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 <797>/<800>, NYSDOH, and Board of Pharmacy regulations.

Nice To Haves

Advanced degree (M.S., MHA, MBA, or equivalent).
Completion of PGY1 residency required; PGY2 Health-System Pharmacy Administration and Leadership (HSPAL) preferred.
Board Certification (BCPS or other applicable specialty certification) preferred.
ASHP Pharmacy Leadership, Regulatory, or Medication Safety certifications preferred.
Experience in multi-site or integrated health system pharmacy operations strongly preferred.
Experience leading enterprise-level regulatory, quality, diversion, or operational initiatives preferred.

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.
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.
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.
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 <797>/<800> compliance, sterile compounding oversight, hazardous drug handling, and environmental safety practices.
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.
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.
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.