Note: The job is a remote job and is open to candidates in USA. Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are seeking a highly experienced Inspection Readiness Project Manager to drive enterprise-wide inspection readiness, remediation, and quality system execution across clinical programs.

Responsibilities

• Lead and maintain a global inspection readiness processes, timelines, and activities
• Collaborate closely with Kyverna QA, Clin Ops, Safety, Biometrics and other functions as needed to develop, align and drive inspection readiness remediation activities
• Partner with Inspection readiness taskforce to define and operationalize inspection readiness frameworks, playbooks, and governance models
• Establish inspection simulation strategies, including mock audits and risk assessments
• Own end-to-end remediation planning and execution following audits/inspections
• Track and manage inspection findings, risks, and commitments through centralized dashboards
• Escalate risks proactively and implement mitigation strategies
• Build and manage integrated, cross-functional project plans with clear milestones and dependencies
• Drive accountability across stakeholders to meet critical timelines and deliverables
• Develop resource plans to support inspection readiness and remediation activities
• Partner with Quality to develop, refine, and implement SOPs, work instructions, and procedural documentation
• Ensure processes are aligned with GCP (Good Clinical Practice) and broader GxP requirements
• Influence without authority to drive execution across a matrixed organization

Skills

• Bachelor's degree required
• 10+ years in biotech/pharma with experience in inspection readiness and remediation programs is a must
• Strong exposure to GCP, GxP, and global inspections
• Deep understanding of clinical trial processes, quality systems, and regulatory expectations
• Exceptional program management skills (complex, global, cross-functional initiatives)
• Ability to drive execution under pressure and tight regulatory timelines
• Strong stakeholder management and executive communication skills
• Advanced degree (MS, PhD, MBA)
• Expertise in audit/inspection processes
• Experience in cell and gene therapy or other complex modalities
• Background in building or scaling inspection readiness programs from scratch
• Familiarity with clinical trial systems (e.g., TMF platforms, QMS tools)

Company Overview

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