What are the responsibilities and job description for the Head of Quality Assurance position at KSQ Therapeutics?
The Head of Quality Assurance will lead all QA activities for KSQ. The leader in this highly visible role will support all our pre-clinical and clinical programs, and will help scale the company as we build for late-stage clinical and commercial launch.
• Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Ensure compliance with quality expectations and industry guidelines in the areas of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Further build out Quality Systems that are compliant, sustainable, scalable, and efficient
• Serve as a model for collaboration with internal and external partners
• Establish and maintain Quality Agreements with our external partners
• Provide oversight and approval of all Quality documentation including, but not limited to change controls, CAPAs, deviations, standard operating procedures, and batch records.
• Track and trend Quality System event generation, and provide periodic updates to company leadership
• Qualify and audit all GMP vendors
WHAT YOU’LL BRING TO THIS ROLE
• BS/BA in a science/engineering field and a minimum of 10 years working in Quality, with experience in cell therapy (or applicable) environment preferred.
• Demonstrated leadership within cross-functional teams with driving a Quality Culture and continuous improvement
• Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
• Ability to build a team by attracting, retaining, and developing top talent
• Experience in building, maintaining, and optimizing a Quality Management System
• Specific skills include, but are not limited to Deviation/CAPA Management, Change Control, Vendor Management (including auditing and quality agreements)