Senior Mgr, IT GxP Business Partner

📋 Description

• • Kyverna Therapeutics is seeking a highly motivated and experienced Senior Manager, IT GxP Business Partner to join our dynamic Information Technology organization. This pivotal role is instrumental in advancing our mission to develop groundbreaking cell therapies for patients suffering from autoimmune diseases. You will be at the forefront of innovation, contributing to our efforts in synthetic biology, immunology, and cell engineering, all while embodying our core values: Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome.
• • As the Senior Manager, IT GxP Business Partner, you will serve as a key liaison between the Information Technology department and our GxP (Good Practice) regulated business units. Your primary responsibility will be to ensure that IT systems and processes supporting GxP activities are compliant with regulatory requirements, robust, and effectively meet the needs of the business. This involves a deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, Part 210/211, ICH guidelines) and their implications for IT systems throughout their lifecycle, from validation and implementation to ongoing maintenance and retirement.
• • You will play a critical role in the strategic planning, implementation, and ongoing management of IT solutions that directly impact GxP-regulated processes. This includes overseeing the validation of GxP systems, ensuring data integrity, and maintaining the security and reliability of all IT infrastructure and applications used in research, development, clinical trials, and manufacturing. Your expertise will be crucial in guiding the organization through the complexities of regulatory compliance in a rapidly evolving biopharmaceutical landscape.
• • Key responsibilities will encompass developing and executing IT strategies aligned with GxP compliance objectives. You will be responsible for managing IT projects related to GxP systems, ensuring they are delivered on time, within budget, and meet all quality and regulatory standards. This includes defining project scope, developing project plans, managing resources, and mitigating risks. You will also be involved in the selection and implementation of new GxP-relevant software and hardware, ensuring thorough validation and integration with existing systems.
• • Furthermore, you will act as a trusted advisor to business stakeholders, providing expert guidance on IT best practices, regulatory requirements, and system optimization. You will foster strong relationships with Quality Assurance, Clinical Operations, Regulatory Affairs, and other GxP-dependent departments to understand their needs and translate them into effective IT solutions. This collaborative approach is essential for ensuring that IT systems not only meet compliance mandates but also enhance operational efficiency and support business objectives.
• • You will be responsible for establishing and maintaining IT policies, procedures, and documentation relevant to GxP compliance. This includes developing and implementing Standard Operating Procedures (SOPs) for system validation, change control, data management, and disaster recovery. Your role will involve conducting regular audits and assessments of GxP systems to identify potential compliance gaps and implement corrective actions. You will also lead efforts to prepare for and respond to regulatory inspections, ensuring that all IT-related documentation and systems are audit-ready.
• • The Senior Manager will also be responsible for managing vendor relationships for GxP-related IT services and solutions, ensuring that third-party providers meet Kyverna's quality and compliance standards. This includes contract negotiation, performance monitoring, and ensuring adherence to regulatory requirements.
• • In addition to system validation and compliance, you will contribute to the overall IT strategy, focusing on how technology can best support Kyverna's growth and innovation in cell therapy. This includes staying abreast of emerging technologies and industry trends that can enhance GxP processes and improve patient outcomes. Your insights will be invaluable in shaping the future of IT at Kyverna, ensuring we remain at the cutting edge of both scientific advancement and regulatory adherence.
• • This role requires a proactive and strategic mindset, with the ability to manage multiple priorities in a fast-paced environment. You will be expected to lead by example, demonstrating strong analytical, problem-solving, and communication skills. Your ability to influence stakeholders at all levels and drive consensus will be critical to your success in this position. By joining Kyverna, you will be part of a patient-centered organization dedicated to making a tangible difference in the lives of individuals affected by autoimmune diseases.