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