Sofie Sarl - Kansas City, MO

posted 3 months ago

Full-time - Senior
Kansas City, MO
Chemical Manufacturing

About the position

The Regional Director of Operations at SOFIE is a pivotal role responsible for overseeing the efficient and cost-effective operation of all radiopharmacy sites within a designated region. This position requires a strategic leader who can ensure that each site meets performance targets while adhering to regulatory compliance and quality standards set forth by SOFIE. The Regional Director will be accountable for the overall performance and achievement of milestones for each radiopharmacy site, managing Site Managers and collaborating closely with SNI management to set and achieve quarterly and yearly goals related to revenue, scheduling, quality, and budget. In this role, the Regional Director will ensure that all radiopharmacy sites comply with regulatory and safety standards, working in conjunction with the Regulatory department and Site Managers to implement quality control and quality assurance processes. The position also involves working with other Regional Directors and SNI management to develop and implement standardized processes across all SNI sites. The Regional Director will be responsible for devising, implementing, managing, and executing projects that optimize performance and operations at each site, which may include overseeing the entire workflow of dose preparation and delivery to customers. The role requires the use of various analytical tools, such as six-sigma and data analysis, to identify and mitigate resource, time, and budget constraints effectively. The Regional Director will also be tasked with organizing and reporting quantitative performance results to SPI management, maintaining accurate documentation to track metrics related to performance, yields, and costs. Additionally, the position involves collaboration with the Sales Team to support business development plans and maintain customer relations, as well as working with the New Products team to implement contract manufacturing products. The Regional Director will interact with multi-disciplinary teams, providing consultation on radiopharmaceuticals to healthcare professionals and representing SPI at scientific and healthcare conferences. The role demands a proactive approach to site emergencies and a commitment to maintaining SPI's company culture across all sites. This position requires significant domestic travel, up to 75%, to ensure effective oversight of operations across the region.

Responsibilities

  • Accountable for the overall performance and achievement of milestones for each radiopharmacy site within their region.
  • Manage all Site Managers within their region.
  • Work closely with SNI management to set and achieve quarterly/yearly milestones for revenue, schedule, quality, budget, etc.
  • Ensure each radiopharmacy site meets all regulatory and safety standards (e.g., state, federal, internal, etc.).
  • Work with Regulatory department and Site Managers to implement QC/QA processes.
  • Devise, implement, manage, and execute projects across multiple disciplines to optimize performance and operations at each radiopharmacy site.
  • Organize and report quantitative performance results to SPI management.
  • Create and maintain accurate documentation to track relevant metrics related to each radiopharmacy's performance, yields, costs, etc.
  • Work with the Sales Team to support FDG (and other “routine” product) business development plans within the region.
  • Maintain existing customer relations from an operational perspective.
  • Identify and communicate plans for growth, including new contracts, to sites.
  • Determine the operational impact of every new contract to each site and work with Sales to inform on the most efficient and cost effective way to execute doses.
  • Interact with multi-disciplinary teams and maintain a high standard of performance and professionalism across teams.
  • Provide information and/or consultation associated with radiopharmaceuticals to physicians, healthcare workers, customers, etc.
  • Attend and present at scientific/healthcare conferences and other professional meetings/committees as a representative of SPI.
  • Respond efficiently and assertively to any site emergencies.
  • Establish a basic understanding of all radiopharmacy equipment and maintenance.
  • Maintain open communication with all departments across SPI.

Requirements

  • B.S. required; M.S., Ph.D., or Pharm.D. from an accredited college preferred.
  • 10+ years of previous experience with operations and facilities management (preferably in a radiopharmacy or laboratory environment) required.
  • 10+ years of personnel management experience required.
  • Background in Nuclear Pharmacy, Positron Emission Tomography (PET) and the manufacture of PET radiopharmaceuticals preferred.
  • Understanding of and experience with Quality processes for production/manufacturing (six-sigma, lean, critical parameters, design of experiments, etc.) preferred.
  • Strong experience in project management required.
  • Strong experience in quality management, including the ability to identify and correct issues, required.
  • Experience in business development and sales preferred.
  • Ability to generate and analyze financial documentation (P&L statements, balance sheets, revenue models, etc.) preferred.
  • Ability to problem-solve, handle customer service issues, and exercise independent judgment and discretion required.
  • Strong interpersonal skills for interacting with employees, physicians, customers, and vendors required.
  • Proficient in MS Office required.
  • Experience with Windows based pharmacy systems (LIMS) preferred.

Nice-to-haves

  • Experience in business development and sales preferred.
  • Familiarity with Cyclotrons preferred.
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