Director, Quality Assurance Operations
May 23
🏢 In-office - Bay Area
Description
• Building and leading the Quality Assurance Operations team • Establishing relationships with internal personnel and external consultants/contractors • Working cross-functionally with other departments to meet company objectives • Managing QA operations to support CMC operations and clinical activities • Ensuring cGMPs compliance for clinical manufacturing • Leading lot disposition activities, validation programs, and quality risk management • Providing oversight for raw material program • Driving continuous improvement initiatives
Requirements
• Bachelor’s Degree in scientific or relevant disciplines in life sciences • 10+ years of experience within the life sciences industry with 6+ years in a Quality Assurance role • 5+ years of direct management experience • Demonstrated mastery of cGMP regulations and quality systems • Thorough knowledge of applicable regulatory requirements • Experience with Health Authority Inspections • Proficiency with electronic management systems • Strong interpersonal and communication skills • Outstanding planning, organization, and multitasking skills • Travel as required • Prior cell therapy experience is a plus
Benefits
• Comprehensive benefits and Paid Time (PTO) plans beginning on the first day of employment • Opportunity to work in a growing, dynamic environment
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