Pharmacy Regulatory Compliance Manager

Cedars-Sinai Medical Center is an 886-bed non-profit, acute, quaternary, teaching Level I Trauma Center hospital located in the heart of Los Angeles, California. The Department of Pharmacy has over approximately 400 staff members who provide comprehensive inpatient pharmacy services as well as outpatient services via 2 cancer centers and 3 outpatient pharmacies. The Department of Pharmacy is committed to the education and training of pharmacists, students/interns, residents, technicians, and other health care professionals. Cedars-Sinai Medical Center (CSMC) is affiliated with several Schools of Pharmacy and offers PGY1 and PGY2 residency programs. The residency and student experiential programs at CSMC continue to grow with every successive year, where nearly 100 residents have graduated from the PGY1 pharmacy residency program since 1985 and more than 200 student rotations are offered at CSMC annually. Recently, CSMC was recognized and bestowed "Site of the Year" awards by two major affiliated CA Schools of Pharmacy for providing an exceptional experiential learning environment for their students.

As a Pharmacy Regulatory Compliance Manager at Cedars-Sinai Medical Center, you will be lead the pharmacy department's regulatory compliance program and assisting the Chief Pharmacy Officer and Pharmacist-In-Charge with quality, regulatory, and performance improvement initiatives. They will ensure compliance with regulatory agencies including but not limited to: The Joint Commission, Department of Public Health, DEA, and California State Board of Pharmacy. They are responsible for supervising the Regulatory and Surveillance Teams.

Problems encountered are of a high level of scope and complexity. This position requires significant organizational, problem-solving and regulatory language interpretation skills as well as emotional intelligence in dealing with both internal and external stakeholders. Employee must take initiative to continually learn and maintain clinical, operational and regulatory knowledge.

• You will ensure department compliance with state and federal laws, accreditation, professional and other regulatory agencies standards and licensure requirements.
• You will maintains abreast of all current regulatory standards relevant to pharmacy practice.
• Interprets regulatory requirements and educates Pharmacy and medical center staff on a routine basis.
• You will collaborate with various medical center departments to ensure regulatory compliance of medication management processes.
• Develops, coordinates, and performs gap analyses, tracers, and other risk evaluations to ensure regulatory compliance.
• Maintains and updates the Pharmacy Policy and Procedure Manual, medication-related policies in the hospital manuals, and Pharmacy regulatory educational materials to ensure compliance with
• Maintains records of authorized medication storage areas and ensures their monthly inspection as required.
• Coordinates medication recalls and ensures complete documentation.
• Coordinates pharmacy staff training and competencies.
• Coordinates the medical center's controlled-substance surveillance program.
• Ensures controlled substance accountability through collaborations with medical center departments including but not limited to Anesthesia, Nursing, Risk Management, Office of Licensure Accreditation and Regulation, and Human Resources on policies/procedures and processes.
• Develops, coordinates, and performs audits of controlled substance transactions to ensure dose accountability.
• Serves on the medical center's controlled substance committees and disseminates relevant information.
• Maintains complete and accurate records of controlled substance distribution.
• Educates medical center staff on controlled substance requirements, policies, and best practices for ensuring accountability.
• Coordinates the PGY2 Health-System Administration and Leadership Resident program in compliance with applicable accreditation standards