TCT/GMP QA Coordinator — Quality & Compliance Lead

Loma Linda University Health; Loma Linda (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Loma Linda University Health is seeking a Coordinator-TCT/GMP Quality Assurance to oversee quality assurance and regulatory compliance for the LLUH TCT/GMP Laboratory. You will manage the QMS, SOPs, audits, CAPA programs, inspection readiness, regulatory submissions, and staff training, ensuring adherence to FDA, FACT, IRB, and other standards.

The role requires a Bachelor's degree in Life Sciences and at least five years in a regulated clinical or manufacturing setting, with preference for a

Qualifications

• Bachelor's degree in Life Sciences or equivalent required.
• Master's degree preferred.
• Five years of experience as a Quality Specialist or Coordinator in regulated clinical, blood, tissue banking, or manufacturing environment preferred.

Responsibilities

• Oversees quality assurance and regulatory compliance activities for LLUH TCT/GMP Laboratory.
• Manages the Quality Management System (QMS), including SOPs, audits, CAPA programs, and inspection readiness.
• Prepares regulatory submissions and accreditation support; staff training and documentation control.
• Collaborates with laboratory leadership, investigators and institutional stakeholders to support compliant cellular therapy manufacturing operations.
• Leads process improvement initiatives and monitors supplier and material quality.
• Provides operational support for TCT/GMP production and quality control activities.

Skills

GxP compliance

QMS

Regulatory standards

English proficiency

Audits

Process improvement

Documentation & reporting

Education

Bachelor's degree in Life Sciences

Master's degree

Job description

Loma Linda University Health is seeking a Coordinator-TCT/GMP Quality Assurance to oversee quality assurance and regulatory compliance for the LLUH TCT/GMP Laboratory. You will manage the QMS, SOPs, audits, CAPA programs, inspection readiness, regulatory submissions, and staff training, ensuring adherence to FDA, FACT, IRB, and other standards.

The role requires a Bachelor's degree in Life Sciences and at least five years in a regulated clinical or manufacturing setting, with preference for a