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About Duke University Hospital
Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States and is the number one hospital in North Carolina, according to U.S. News and World Report for 2023-2024. Duke University Hospital is the largest of Duke Health's three hospitals and features 1048 patient beds, 65 operating rooms, as well as comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
Location:
Duke Hospital, Durham, North Carolina
Work Hours:
Standard
General Description
As a key member of the Duke Health pharmacy leadership team, the Director of Pharmacy Compounding Operations is responsible for overseeing the development, implementation, and adherence to policies and regulatory compliance within the organization's compounding facilities. This role includes supervision of both sterile and non-sterile pharmaceutical compounding operations. Oversee the Duke Compounding Facility, ensuring compliance with Joint Commission Medication Management standards, USP Compounding Chapters, and North Carolina State Board of Pharmacy regulations. Collaborate with cleanroom Pharmacy Managers to maintain performance standards and serve as the subject matter expert in pharmacy compounding. Standardize compounding processes and address inconsistencies while fostering a culture of excellence and compliance throughout the health system. Implement strategic initiatives authorized by the health system, ensuring effective collaboration and communication across relevant departments. Manage human, financial, and informational resources within the areas of oversight. The Director will report to the Senior Associate Chief Pharmacy Officer and is pivotal in promoting best practices within the pharmacy compounding operations across the health system.
Duties and Responsibilities
General Responsibilities
* Develop and implement policies for DUHS compounding cleanroom sites, ensuring Pharmacy Manager compliance and documentation maintenance, as well as providing regulatory education.
* Oversee facility performance related to the preparation of compounded sterile (CSPs) and nonsterile preparations (CNSPs).
* Ensure compliance with USP Compounding Chapters and relevant state and national regulations.
Leadership Functions
* Provides oversight for Duke Compounding Facility operations.
* Promote collaboration across departments, facilitating problem-solving and addressing complaints with integrity and professionalism. Provide in-service education and drug information to colleagues and stakeholders as needed.
* Develop and enforce departmental policies to ensure compliance with hospital, health system, and applicable state and federal regulations.
* Plan and conduct meetings with staff to ensure compliance, implement new policies, and update employees on changes in standards. Manage personnel actions, including hiring and promotions.
* Perform related duties as required.
Engineering Controls and Facilities Management
* Act as the pharmacy expert for future facility builds and renovations.
* Support area leaders with facility requests, such as temperature adjustments and cleaning.
* Standardize engineering certification across the system, serving as the main contact for contractors and vendors.
* Review engineering certifications and ensure necessary corrective actions and documentation are completed.
* Liaise between Engineering and Operations during critical facility maintenance, ensuring proper cleaning and testing protocols before resuming patient care.
* Coordinate cleaning efforts by 3rd party contractors and DUHS personnel, including maintaining training and documentation for cleaning schedules.
* Implement cleaning policies for non-sterile compounding and repackaging areas.
* Select and standardize supplies and equipment to ensure availability and compatibility.
Personnel Competency Development and Performance Management
* Standardize required personnel (including Manager) training, including didactic and observation competency for all areas.
* Coordinate with frontline leaders (work unit or pharmacy cleanroom specific "Designated Person") when personnel are out of compliance or due for annual didactic training. In collaboration with the appropriate member of the Senior Management Group, perform corrective action as necessary.
* Serve as the point of contact for issues or needs regarding our didactic training LMS (Critical Point).
* Provide oversight for procedures related to media fill tests for all sterile compounding staff. Ensure related procedures are established based on the latest regulatory standards and thorough follow-up (including documentation is maintained).
Environmental Monitoring and Control
* Standardize training for all personnel, including management, covering didactic and observation competency.
* Coordinate with frontline leaders on compliance issues related to annual didactic training, and collaborate with Senior Management for corrective actions.
* Serve as the contact for didactic training LMS (Critical Point) needs and issues.
* Oversee media fill test procedures for sterile compounding staff, ensuring compliance with the latest regulatory standards and maintaining thorough documentation.
Quality Management and Regulatory Compliance
* Maintain quality assurance (QA) and quality control (QC) programs.
* Standardize beyond-use-date (BUD) and hazardous drug (HD) policies across all areas, including sterile, non-sterile, inpatient, and retail.
* Offer expertise in extending BUDs for non-sterile and sterile products, including repackaging.
* Standardize product master formulation and compounding records.
* Collaborate with designated persons to develop and maintain compounding policies, reviewing them annually for current practices.
* Provide regulators with information on compounding training, facilities, cleaning, and compliance record
Minimum Qualifications
Education
Work requires a bachelors or doctorate in Pharmacy. preferred. A masters in Business Administration or Pharmacy Administration
Experience
Three years clinical experience in a supervisory position program. OR completion of a non-management pharmacy residency program and two years of supervisory experience OR completion of a health system pharmacy administration residency.Preferred: experience working in compounding facility
Degrees, Licensures, Certifications
North Carolina Pharmacist's License required. Certification in basic life support preferred.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
