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
Company H1B Sponsorship