Senior Director, Quality Systems

Role Overview

• Develop, implement, and manage Kyverna’s Quality Management System.
• In close collaboration with Technical Operations and Clinical Functions, define the requirements for a late phase and commercial lifecycle stage-appropriate quality system.
• Drive the maturation and continuous improvement of the QMS to support clinical development through commercialization.
• Represent Quality and provide Quality leadership on cross-functional project and program teams, as required.
• Ensure compliance with all applicable regulations, industry best practices, and standards related to Kyverna products. Adapt the QMS per region-specific requirements as required.
• Serve as the Quality business process owner (BPO) and provide oversight for Change Management, Deviation/CAPA Management, Document Lifecycle Management, Records Management, Training Program, Quality Risk Management, Computer Systems Quality Assurance, Quality Management Review, and Quality Governance Boards.
• Lead Quality Management Review and Quality Governance Board (such as Material Review Boards, Specification Review Boards, Change Control Review Boards, etc.) meetings and monitor the state of control of Kyverna’s QMS.
• Set and/or facilitate establishment of key performance indicators and metrics. Perform trend analysis and assess QMS processes for potential gaps to ensure compliance and to monitor the health of the QMS. Ensure proper communication and escalation to peers, senior, and executive management as required.
• Assist in the development and deployment of quality systems in accordance with ICH Q 8,9,10 model, PDA TR 56, and other industry best practices.
• Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas.
• Evaluate, identify, and drive continuous improvement opportunities to maintain product quality and improve process effectiveness in the overall QMS lifecycle.
• Oversee and manage the electronic Quality Management System (eQMS), including workflow configuration and the continued validation of the system.
• Support inspection readiness activities including assessment and oversight of Kyverna records, storyboard, and inspection logistics.
• Participate in audits and inspections representing Quality Systems.
• Support Regulatory Filings as required.
• Manage a budget for implementation of quality tools and training.
• Support processes and work with contract service providers providing manufacturing and testing and clinical services.
• Manages and mentors a team of highly performing individuals.

Requirements

• Bachelor's degree and 10+ years’ experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area and relevant Quality Systems experience, ATMP experience preferred.
• 4+ years’ personnel management experience
• In-depth knowledge of cGMPs, FDA regulations (21 CFR Parts 210, 211, 11), EudraLex, ICH Guidelines, etc.
• Working knowledge of GXP regulations and guidelines, as it pertains to Quality Systems
• Experience with implementation and qualification of an eQMS
• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on compliance and efficiency
• Ability to work effectively with various technical groups
• Ability to work in a collaborative team environment is essential, with a customer-focused approach
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Must have strong interpersonal and communication skills
• Expert level experience writing, reviewing and editing SOPs, as well as other document types.

Benefits

• Annual bonus
• Equity
• Benefits
• Participation in the Company’s stock plan