Job Summary
The Director of Quality Assurance plays a crucial role in delivering strategic guidance to guarantee adherence to cGMP, FDA, and DEA regulations throughout all manufacturing activities. This position involves the supervision of quality systems, management of regulatory audits, and the execution of CAPA initiatives, while fostering collaboration across various departments to uphold exemplary product quality standards.
Responsibilities
- Provide strategic leadership to ensure compliance with industry regulations.
- Oversee quality assurance systems and manage regulatory inspections.
- Lead CAPA initiatives to promote continuous improvement.
- Collaborate with cross-functional teams to maintain high standards of product quality.
Qualifications
- Bachelor’s degree in a scientific field.
- A minimum of ten years of progressive leadership experience in quality assurance within a cGMP-compliant pharmaceutical setting.
- In-depth knowledge of regulatory standards, quality management systems, and validation processes is essential.
