GMP QC Lead - Cell Therapy Release & Compliance

Vertex Pharmaceuticals Inc (US); Greater London; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Vertex is seeking a QC leader in London to oversee external QC testing for a gene edited cell therapy product. The role focuses on GMP release and stability testing, with responsibility for compliance and continuous improvement across contract labs and internal processes.

You will coordinate data reviews, SOPs, and COAs, and ensure external lab records meet regulatory expectations while managing timelines and risk communication with management.

Qualifications

• Bachelor’s Degree in science or related discipline is required.
• Typically requires 8 years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.
• Experience managing GMP external contract test labs

Responsibilities

• Acts as the lead point of contact for QC activities at contract manufacturers and test organizations, including release & stability testing, validation, and adherence to timelines.
• Manages QC operations for a gene edited hemoglobinopathy cell therapy product and troubleshoot analytical methods related to release of biologics and cell therapy products.
• Manages commercial reference standards and assay controls programs to ensure compliance and continuity of supply for commercial demands.
• Assists in troubleshooting analytical methods and/or equipment as required.
• Authors, reviews, or approves data, SOPs, COAs, analytical methods, protocols, and reports.
• Ensures external laboratory records adhere to cGMP/GDP expectations.
• Leads compliance-related teams towards continuous improvement.
• Leads OOS/OOT investigations/deviations and identifies corrective actions to prevent recurrence

Skills

cGMP knowledge

Analytical testing experience

Regulatory inspections experience

Effective communication skills

Biologics assay experience

Education

Bachelor’s Degree in science or related discipline

Tools

LIMS

Job description

Vertex is seeking a QC leader in London to oversee external QC testing for a gene edited cell therapy product. The role focuses on GMP release and stability testing, with responsibility for compliance and continuous improvement across contract labs and internal processes.

You will coordinate data reviews, SOPs, and COAs, and ensure external lab records meet regulatory expectations while managing timelines and risk communication with management.