Associate Director, Quality Assurance

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.

Kyverna is recruiting an Associate Director, Quality Assurance in its Technical Operations organization to help advance its mission to free patients from the siege of autoimmune disease. The Associate Director will be responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) in support of clinical manufacturing, establishment of internal QA batch review and release processes, and maintenance of the manufacturing processes for investigational product.

The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.

Responsibilities

• In collaboration with Manufacturing, Process and Analytical Development, and Quality Control, implement and maintain control strategies for Kyverna’s clinical products including ownership of the product release process.
• Develop and maintain Kyverna’s CMO oversight program, including establishment of Quality Metrics and process monitoring practices.
• Manages and directs Quality Assurance staff responsible for batch release and CMO oversight.
• Perform QA/client review and approval for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.
• On-site oversight of CMO operations as needed to support the programs
• Liaise with Supply Chain to ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sites
• Support Manufacturing to develop and monitor key performance indicators to ensure effective oversight of CMO and contract/external laboratories.
• Draft, review, maintain, and execute against Quality Agreements with Supplier/CMO network.
• Lead and drive “right the first time” performance with CMOs to ensure clinical program expectations are met.
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
• Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
• Support business development due diligence projects as needed in order to support assessment of internal/external manufacturing capabilities.
• Other duties as assigned.

Requirements

• Degree (Bachelors or higher) or equivalent experience in life sciences, Biochemistry, Chemistry, Biotechnology
• 10+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience in the field of cell therapies preferred.
• Experience leading and developing a small team of up to 5 individuals.
• Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for late-phase and commercial biopharmaceutical products and ATMPs.
• Demonstrated ability to manage multiple complex relationships within a CMO network
• Experience with electronic Quality Management Systems
• Experience in conducting or hosting Quality and/or Health Authority audits.
• Excellent interpersonal, verbal and written communication skills
• Ability to function efficiently and independently in a changing environment
• Ability to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.
• Must be willing to travel up to ~50% of the time, depending on manufacturing schedule.
• Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills
• Strategic thinking and high emotional intelligence
• Manage and advance multiple projects simultaneously and dynamically reprioritize as needed
• Demonstrated capacity to think creatively when addressing complex situations
• Ability to communicate effectively with Kyverna Leadership, clinical, and development scientists, and with external business partners and Regulatory Authorities.