Job Title: Clinical QA Inspection Readiness Consultant (237704)
Location: Remote – potential onsite travel once a month
Duration: 12+ months
Start Date: ASAP
JOB SCOPE:
The Clinical QA Inspection Readiness Consultant will act as a Clinical Quality Lead supporting GCP compliance for ongoing Phase I–III clinical studies in cell therapy. Responsibilities include developing audit plans and strategies, conducting internal and external audits (vendors and sites), managing inspection readiness activities, writing SOPs, scheduling and executing mock inspections, supporting GCP system implementation, addressing audit backlog, and preparing for a pivotal BLA submission. The consultant will also train staff, develop quality templates, escalate risks, and provide regulatory guidance across clinical functions.
Requires additional bandwidth to support inspection readiness, SOP creation, audit backlog, and GCP system implementation across five pivotal Phase II studies.
GENERAL RESPONSIBILITIES:
- Act as a Clinical Quality Lead by supporting study team compliance with national and international regulatory standards and guidance for cell therapy products.
- Develop audit plans and audit strategy for ongoing clinical trials.
- Performs initial and ongoing audit of clinical vendors such as CRO, imaging core lab, central laboratory and other vendors as needed
- Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines
- Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
- Participate in the development of clinical standard operating procedures, work instructions, forms, and templates.
- Develop and conduct training for staff (GCP, Inspection Readiness training, etc.).
- Support preparation for and execution of regulatory inspections.
- Identify and escalate site, vendor and study related risks and issues to management, as appropriate.
- Provide quality and regulatory compliance guidance to clinical team members in clinical operations, biostatistics, data management, medical monitoring, and pharmacovigilance.
Clinical QA Inspection Readiness Consultant (237704)
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