Director of Quality Assurance

Job Description :

Director of Quality Assurance

The Director of Quality Assurance leads and oversees all QA programs to ensure compliance with FDA regulations for drug products. Responsibilities include managing QA teams, supervising release of materials and products, maintaining the Quality Management System, and ensuring adherence to cGMP standards. This role involves developing SOPs, conducting audits, managing change control, investigating deviations, and acting as the primary liaison during client and regulatory audits.

Key Duties :

• Lead and manage the QA team including hiring and training.
• Oversee daily QA operations and Quality Management System.
• Develop and maintain SOPs and inspection standards.
• Administer auditing and cGMP training programs.
• Manage change control and review manufacturing and testing procedures.
• Investigate production discrepancies and ensure quality controls.
• Participate in meetings, manage QA budget, and handle personnel decisions.

Qualifications :

Details :