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

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)

Inspection Readiness Project Manager – Contract

Key skills