Kyverna - Therapeutics - Inspection Readiness Project Manager (Contract)
Requirements
• Bachelor’s degree required; advanced degree (MS, PhD, MBA) preferred • 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 • Expertise in audit/inspection processes preferred • 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 • Experience in cell and gene therapy or other complex modalities strongly preferred • Background in building or scaling inspection readiness programs from scratch • Familiarity with clinical trial systems (e.g., TMF platforms, QMS tools)
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
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