Director/ Senior Director of Quality

Job Description

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

Responsibilities:

• 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.

Requirements:

• 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