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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.
Responsibilities
Core Leadership Competencies
• 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 <797>/<800> 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
Minimum 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 <797>/<800>, NYSDOH, and Board of Pharmacy regulations.
Preferred Qualifications
? 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.
Non-Bargaining Unit, 600 - HSO Pharmacy - MSH, Mount Sinai Hospital
About Us
Strength through Unity and Inclusion
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
About the Mount Sinai Health System:
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
Equal Opportunity Employer
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.