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Associate Director QC

Company: Fresenius Kabi USA
Location: Wilson
Posted on: June 20, 2022

Job Description:

POSITION SUMMARYDirectly and through subordinates and peers, the Associate Director of Quality Control leads a multifunctional team comprised of Quality Control Analytical, Microbiology, Stability, Incoming Quality Control, and Technical Services for the Wilson manufacturing site.PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

  • Oversee the testing of all products manufactured at the Wilson Manufacturing facility. Testing performed includes chemical and microbiological for IQC, raw material, in-process and finished product testing.
  • Direct the Stability program which includes the testing, data analysis and FDA submission and annual report preparation for the Wilson site.
  • Direct root cause analysis associated with laboratory investigations (invalid runs, out of trend, out of specification events). Position is key subject matter expert in evaluating initial event impact and risk.
  • Manages the Quality Control requests during FDA site inspections in Wilson.
  • Direct activities associated with evaluations of processes, results and risks.
  • Monitor USP compendial changes and assure products are compliant with current standards.
  • Drive operational efficiencies and process optimization utilizing KPIs and standard work level loading techniques.
  • Drive synergies, optimize workflows, and streamline functions
  • Drive development of continuous improvement plans and standards; leading teams to execute continuous improvement projects such as 5S and visual management.
  • Ensure department annual product quality review data, key performance indicators, and metrics are reported accurately and on time.
  • Prepare departmental budgets and capital plan and ensure adherence to budgetary goals and execution of the approved capital equipment plan.
  • Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
  • Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
  • Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.REQUIREMENTS
    • Bachelor of Science degree required, advanced degree in chemistry, microbiology or engineering fields strongly preferred.
    • Minimum of 10 years relevant experience in injectable, aseptic pharmaceutical manufacturing operations with at least 7 years of proven leadership.
    • Significant quality control laboratory, technical operations and management experience.
    • Proven leadership ability in managing and leading multidisciplinary teams
    • Proven experience in devising and leading change, results orientation, action bias
    • Strong analytical problem-solving experience essential. Demonstrated ability to troubleshoot and resolve complex technical and manufacturing problems.
    • Ability to effectively interact with and influence third party partners, suppliers/vendors, regulators, global partners or affiliates, industry executives and trade organizations.

Keywords: Fresenius Kabi USA, Wilson , Associate Director QC, Executive , Wilson, North Carolina

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