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
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)