Senior Director, 503B Outsourcing

Check out the role overview below If you are confident you have got the right skills and experience, apply today.Job Summary:Responsible for overseeing and managing the day-to-day operations at the 503B outsourcing facility. Ensures site operations and processes are integrated and meet US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), US Pharmacopeia (USP), Board of Pharmacy requirements and industry best practices. Provides leadership in assuring department alignment in achieving organizational expectations of employee engagement, distinctive patient services, provision of quality and safe services, strategic planning, and fiscal responsibility. Acts as a communicator, facilitator, and translator of the organizational expectations. Ensures managers and staff have the human and fiscal resources to effectively accomplish an engaged workforce, distinctive patient services and the provisions of quality and safe services.This is NOT a remote opportunity. This role will require relocation to St. Louis, MO upon acceptance of the role.Job Responsibilities and Requirements:PRIMARY RESPONSIBILITIESDevelops, implements, and monitors day-to-day operational systems and processes to provide visibility into the goals, progress, and obstacles of key initiatives.Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks.Manages various projects related to 503B processes and implementations.Collaborates with executive-level management in the development of performance goals and long-term operational plan.Analyzes market trends for preparation of the production schedule.Sets strategic goals for operational efficiency and increased productivity. Monitors workload statistics to ensure appropriate staffing levels.Implements long-term plans for facility growth, equipment, materials, technology, and workforce resources to maintain manufacturing capacity and processes.Maintains the facility in a constant state of inspection readiness. Ensures staff are compliant with the Food and Drug Administration's current good manufacturing Practice (cGMP) regulations and related elements such as facilities, training, reports, records, and documentation (e.g., standard operating procedures, validation protocols, etc.).Responsible to oversee compliance with US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Boards of Pharmacy regulations as they relate to Section 503B of the Food, Drug and Cosmetic Act (FDCA).Recruits, engages, develops, leads, and manages assigned staff.Works in a constant state of alertness and safe manner.Performs other duties as assigned.#J-18808-Ljbffr

Created: 2024-11-06