Director/ Senior Director of Quality


Nebraska City, NE


As a Director of Quality, you will be responsible for leading and overseeing Quality Assurance (QA) and Quality Control (QC) departments.


  • You will manage and oversee product release activities including batch record review, product disposition, returns, salvages, recalls, product improvement and product annual review.
  • You will coordinate and oversee QA/QC personnel task to meet production and company requirements.
  • You will write, review and/or approve Standard Operating Procedures, Specifications and Manufacturing Instructions.
  • You will manage customer complaints and product returns. Write, Review and approve them as needed.
  • You will engage with all departments including Senior Management to assure procedures are followed
  • Manage the planning of company-wide Annual cGMP training management.
  • You will oversee Quality Control operation.
  • You will maintain compliance of all testing methods and technologies used within the Quality Control department.
  • You will review and approve OOS results for release and stability testing.
  • You will develop strategies for continuous improvement and personnel development within the QA and QC departments.
  • You will work with all departments for continuous improvement.
  • You will oversee Investigations/Deviations/CAPA and internal/external audits program.


  • Bachelor’s degree in a scientific discipline.
  • Minimum of ten (10) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
  • Minimum of six (6) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
  • Advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
  • Experience with managing people, including training, conflict resolution and coaching.
  • Excellent time management and organization skills.
  • Strong written and verbal communication and employee relation skills.
  • Proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills
Apply Now