Cell Therapy GMP QA Coordinator — Regulatory Excellence

Loma Linda University Health; Loma Linda (CA); Hybrid; USD 115,000 - 154,000; Full time

Job summary

Loma Linda University Health (LLUH) seeks a Coordinator–TCT/GMP Quality Assurance to oversee QA and regulatory compliance for the LLUH TCT/GMP Laboratory. You will manage the QMS, SOPs, audits, CAPA, and inspection readiness while collaborating with leadership and investigators to support compliant cellular therapy manufacturing operations.

The role requires a life sciences bachelor’s, a preference for a master’s, and about five years in a regulated clinical or manufacturing setting.

Qualifications

• Bachelor's degree in Life Sciences or equivalent required; Master's preferred.
• Five years of experience as a Quality Specialist or Coordinator in regulated clinical, blood or tissue banking or manufacturing environments preferred.
• In-depth knowledge of laboratory safety, GxP compliance and QMS in regulated labs.

Responsibilities

• Oversee quality assurance and regulatory compliance for LLUH TCT/GMP Laboratory.
• Manage QMS, SOPs, audits and CAPA programs.
• Ensure inspection readiness, regulatory submissions, staff training and accreditation support.
• Support compliant cellular therapy manufacturing operations and process improvements.
• Monitor supplier and material quality and prepare compliance reports.

Skills

GxP compliance

Quality Management System (QMS)

CAPA

Audits

Regulatory submissions

Staff training

Process improvement

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

Microsoft Office

LIMS (Laboratory Information Management Systems)

Document control

Job description

Loma Linda University Health (LLUH) seeks a Coordinator–TCT/GMP Quality Assurance to oversee QA and regulatory compliance for the LLUH TCT/GMP Laboratory. You will manage the QMS, SOPs, audits, CAPA, and inspection readiness while collaborating with leadership and investigators to support compliant cellular therapy manufacturing operations.

The role requires a life sciences bachelor’s, a preference for a master’s, and about five years in a regulated clinical or manufacturing setting.