Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Summary

We are seeking a highly experienced Inspection Readiness Project Manager to drive enterprise-wide inspection readiness, remediation, and quality system execution across clinical programs. This individual will serve as the central orchestrator across Clinical Operations, Quality, Regulatory, and external partners to ensure continuous state of inspection readiness for global health authority inspections (e.g., FDA, EMA).

This role requires deep expertise in GxP environments, strong clinical development knowledge, and a proven ability to drive complex, cross-functional initiatives under tight timelines.

Title: Inspection Readiness Project Manager

Location: Remote. West coast highly preferred

Duration: 6+ months

Hourly rate: $80-$100/hr

### 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

### Qualifications

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)

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