On-the-Floor GMP QA Consultant - Gene Therapy

Vita Global Sciences, a Kelly Company; Houston (TX); On-site; USD 185,976,000 - 228,682,000; Full time

Job summary

Vita Global Sciences, a Kelly Company, seeks a Senior GMP Quality Assurance Consultant to provide hands-on QA support for clinical and commercial gene therapy manufacturing. You will review GMP docs, approve batch records, and guide risk-based QA actions in collaboration with Manufacturing, QC, Regulatory, and Technical Operations.

Reporting to the Director of GMP QA, the role emphasizes real-time quality oversight, product disposition support, and ensuring inspection readiness in a fast-paced

Qualifications

• 8+ years of direct GMP Quality Assurance experience in gene therapy.
• QA support on manufacturing floor for gene therapy products.
• Strong knowledge of FDA, ICH, cGMP, deviations and CAPAs.

Responsibilities

• Provide on-the-floor GMP QA oversight for gene therapy manufacturing operations.
• Review and approve batch records, deviations, investigations, CAPAs and change controls.
• Support DS/DP disposition activities and regulatory readiness.
• Evaluate quality issues and provide risk-based QA guidance.
• Review data and method validation documentation for GMP compliance.
• Provide real-time QA guidance during manufacturing and escalate risks.
• Collaborate with Manufacturing, QC, Regulatory, and Technical Operations.
• Assist with regulatory inspections and ensure audit-ready documentation.

Skills

GMP QA

On-the-floor QA

Regulatory knowledge

Education

Bachelor's degree in biology/chemistry/biotechnology/engineering

Tools

Electronic batch records

Electronic QMS

Job description

Vita Global Sciences, a Kelly Company, seeks a Senior GMP Quality Assurance Consultant to provide hands-on QA support for clinical and commercial gene therapy manufacturing. You will review GMP docs, approve batch records, and guide risk-based QA actions in collaboration with Manufacturing, QC, Regulatory, and Technical Operations.

Reporting to the Director of GMP QA, the role emphasizes real-time quality oversight, product disposition support, and ensuring inspection readiness in a fast-paced