The Program Manager manages all Compounded Sterile and Non-Sterile Products and Hazardous Drug (HD) operations for VA North Texas Healthcare System. This includes compliance oversight of all pharmacists, technicians, trainees, and other supportive personnel involved in sterile and non-sterile compounding and/or hazardous drug management

Duties

The Program Manager is responsible for developing and implementing appropriate procedures; overseeing compliance with all USP chapters and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The Program Manager is responsible for the development, organization and management of the Sterile and Non-Sterile Compounding program in compliance with all applicable laws and regulations (e.g. Joint Commission, USP 797, 795, 800, OIG, FDA, DEA, NIOSH etc. and any future regulations in this area). The Program Manager is responsible for maintaining reports of testing/sampling performed in our pharmacy areas and acting on the results. The Program Manager is responsible for all information and automation systems associated with sterile and non-sterile compounding. Thorough knowledge and understanding of various regulations including FDA, DEA, USP, NIOSH, OIG and the Joint Commission and VHA national and local handbooks and directives, policies and standard operating procedures pertaining to the practice of pharmacy is required. The incumbent develops and implements appropriate procedures, oversees and assures facility compliance with USP Chapters 795, 797, and 800 and other applicable laws, regulations, and standards, ensuring competency of personnel, and assuring environmental control of all compounding areas. Reviews sterile and non-sterile compounding policies and procedures at minimum every 2 years or more frequently as needed and recommends updates. Communicates updates and provides informational updates to impacted personnel as needed. The incumbent directs and oversees activities of all assigned operational, technical and professional personnel, with a particular emphasis on assuring that all USP Chapter 795, 797 and 800 CSP compliance requirements are met in Compounding and Hazardous Drug Management due to their inherent high-risk status in regard to the care of our patients. Maintenance of all required processes and documentation for completely meeting USP Chapters 795, 797, and 800 are a primary focus of this position. This includes assigned drug distribution-associated recordkeeping, competency assessments, documentation logs, personnel and process testing reporting for USP Chapters 795, 797, 800 report processing and monitoring including reports of all testing from all contractors and laboratories on facilities, CSPs, and/or components. Collaborates with the facility Quality Management, Safety, Infection Prevention, Engineering, and the Pharmacy Leadership teams to develop a formal written CSP Safety and Quality Assurance (QA) Plan with mechanism(s) for monitoring, evaluating, and implementing a contingency plan to obtain CSPs from another source if the VA facility CSP preparations or delivery are suspended. Consultation for the development and implementation of the Safety and QA Plan will be provided by the multidisciplinary team. Gathers data for administrative reports when assigned. Upon request, independently prepares reports or participates in pharmacy projects. Assists in preparing for special accreditations and reviews (e.g., The Joint Commission, Inspector General, etc.,) and meets with reviewing/inspecting officials and pharmacy management. Supports institutional efforts to construct and maintain the use of Veterans Administration (VA) national formulary that promotes safe and cost-effective use of medications. Provides support to the Medical Staff in drug use policy development and disease management, focusing on appropriate, cost-effective use of therapeutic measures. Provides support to the local and VISN P&T committees to assess and evaluate cost-effective medication use and programs. Participates in the training and in-servicing of pharmacists, pharmacy technicians, pharmacy students, pharmacy residents, and other medical center personnel as requested. Work Schedule: Monday - Friday, (6:00am - 5:30pm) 8-hour work tour per day. Actual tour to be discussed with selected candidate. Hours may be extended or adjusted to meet patient care needs. Telework: Not Available Virtual: This is not a virtual position. Functional Statement #: 000000 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required

Requirements

Qualifications

Basic Requirements: Citizenship. Citizen of the United States. (Noncitizens may be appointed when it is not possible to recruit qualified citizens in accordance with chapter 3, section A, paragraph 3g, this part.) Education: Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited College or School of Pharmacy with a baccalaureate degree in pharmacy (BS Pharmacy) and/or a Doctor of Pharmacy (Pharm.D.) degree. (Must submit a copy of Transcripts) (NOTE: Prior to 2005 ACPE accredited both baccalaureate and Doctor of Pharmacy terminal degree program. Today the sole degree is Doctor of Pharmacy.)(2) Graduates of foreign pharmacy degree programs meet the educational requirement if the graduate is able to provide proof of achieving the Foreign Pharmacy Graduate Examination Commission (FPGEC) Certification, which includes passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language Internet-Based Test (TOEFL iBT). May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria). Licensure. Full, current and unrestricted license to practice pharmacy in a State, Territory, Commonwealth of the United States (i.e., Puerto Rico), or the District of Columbia. The pharmacist must maintain current registration if this is a requirement for maintaining full, current, and unrestricted licensure. A pharmacist who has, or has ever had, any license(s) revoked, suspended, denied, restricted, limited, or issued/placed in a probationary status may be appointed only in accordance with the provisions in VA Handbook 5005, Part II, Chapter 3, section B, paragraph 16. English Language Proficiency: Pharmacists must be proficient in spoken and written English as required by 38 U.S.C. 7402(d), and 7407(d). Grade Determinations: GS-13 Experience. In addition to the GS-12 requirements, must have 1 year of experience equivalent to the next lower grade level. Assignment. Candidates at this grade level are to be in one of the assignments listed below. For all assignments above the full performance level, the higher level duties must consist of significant scope, administrative independence, complexity (difficulty) and range of variety as described in this standard at the specified grade level and be performed by the incumbent at least 25% of the time. Facility Program Manager. Manages all aspects of a distinct program to include policy development, quality resources and specialty functions unique to the program to optimize cost effectiveness (budget) and patient outcomes. Coordinates a single program area of a complex pharmacy operation, or multiple program areas within a facility to develop, organize, manage, and control complex pharmacy programs. Develops, organizes, coordinates and manages single or multiple program areas within the medical facility; this may include a single program area at multiple facilities. The Program Manager title is reserved for those individuals who have one or more of the following: supervisory responsibilities for various sections within Pharmacy Service; a complex program requiring coordination of multiple locations such as medical center care facilities, Community Based Outpatient Clinics (CBOCs), rural health, telemedicine, etc.; specialized areas of a complex nature such as nuclear pharmacy, quality assurance, pharmacy informatics, clinical applications coordinator, Home Based Primary Care, pharmacoeconomist or liaison pharmacist duties requiring the coordination of processes with other medical facilities or VISNs. Demonstrated KSAs. Pharmacists assigned to this position must also demonstrate the following KSAs: a. Ability to communicate orally and in writing to persuade and influence clinical and management decisions. b. Expert understanding of regulatory and quality standards for their program area. c. Ability to solve problems, coordinate and organize responsibilities to maximize outcomes in their program area or area of clinical expertise. d. Expert knowledge of a specialized area of clinical pharmacy practice or specialty area of pharmacy. e. Advanced skill in monitoring and assessing the outcome of drug therapies, including physical assessment and interpretation of laboratory and other diagnostic parameters. Preferred Experience: Program Management Experience Sterile Compounding Experience USP Standards Understanding and Experience References: VA Handbook 5005/55 Part II Appendix G15 dated June 7, 2012 The full performance level of this vacancy is GS-13. Physical Requirements: Moderate Lifting and Carrying (15-44 lbs.); Straight Pulling (up to 1 hour); Pushing (up to 2 hours); Reaching above shoulder; Use of fingers; Both hands required; Walking (up to 4 hours); Standing (up to 8 hours); Repeated bending (up to 1 hour); Ability for rapid mental and muscular coordination simultaneously; Near vision correctable at 13" to 16" to Jaeger 1 to 4; Far vision correctable in one eye to 20/20 and to 20/40 in the other; Ability to distinguish basic colors; ability to distinguish shades of colors; Hearing (aid permitted).

Education

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

NOTE: If your school has changed names, or is no longer in existence, you must provide this information in your application.

Contacts

• Address Dallas VA Medical Center 4500 South Lancaster Road Dallas, TX 75216 US
• Name: VISN 17 SSU USAS Group
• Email: [email protected]