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