About this role
About the Role The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control. This role serves as the Quality representative on cross-functional project teams and ensures Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in compliance with GMP requirements while supporting clinical and commercial operating timelines. What You'll Do
- Provide QA oversight for FEU and CS programs in a cell-therapy manufacturing setting, ensuring alignment with GMP requirements.
- Be accountable for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and ongoing control.
- Serve as the Quality representative on cross-functional project teams.
- Ensure Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in GMP-compliant manner.
- Support clinical and commercial operating timelines. What We're Looking For
- Experience in quality assurance oversight of regulated manufacturing programs (ideally FEU and CS) within a GMP environment.
- Strong understanding of GMP readiness, validation lifecycle activities (commissioning, qualification, validation).
- Proven ability to partner with cross-functional teams and communicate QA findings effectively.
- Track record of ensuring activities are properly planned, documented, and maintained for compliance.