Quality Assurance Director

The Director/Associate Director of Quality Assurance, reporting to VP of Quality & Regulatory, will be responsible for Quality Assurance and Validation team to ensure that the Quality management system and all aspects of cGMP are effectively established, implemented, and maintained in accordance with the regulations for manufacturing of guide RNAs for gene therapy applications. This individual, as the head of QA Department, will be responsible for leading and managing QA operations, Quality events, product disposition, and validation activities.

What You'll Do:

• Provide QA oversight for facility, equipment, manufacturing, testing and release of preclinical and clinical guide RNAs
• Manage incoming raw materials and product disposition activities including
• Provide direct oversight for major investigations/non-conformance events including out of specification events
• Provide oversight for commissioning, qualification and validation activities for the facilities, utilities equipment and computerized systems
• Support audit programs and host customer audits and regulatory inspections
• Manage all QA-related interactions with customers including timely clien...