Associate Director QC
Company: Fresenius Kabi USA
Posted on: June 20, 2022
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
- 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
- Direct the Stability program which includes the testing, data
analysis and FDA submission and annual report preparation for the
- 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
- 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
- Prepare departmental budgets and capital plan and ensure
adherence to budgetary goals and execution of the approved capital
- 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
- 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
- Minimum of 10 years relevant experience in injectable, aseptic
pharmaceutical manufacturing operations with at least 7 years of
- Significant quality control laboratory, technical operations
and management experience.
- Proven leadership ability in managing and leading
- 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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