Senior QC Leader - Gene Therapy Release & Compliance

Vertex Pharmaceuticals LLC; Greater London; Ibrido; GBP 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals LLC is seeking a senior QC lead to coordinate QC activities at contract manufacturing and testing organizations, focusing on release testing, stability, and compliance with cGMP standards. You will manage reference standards, troubleshoot analytical methods, and lead investigations to drive continuous improvement.

The role requires a Bachelor's in science and roughly 8 years in the pharmaceutical/biopharmaceutical industry, with experience managing GMP external contract

Competenze

• Bachelor's Degree in science (required).
• Typically requires 8 years of experience in pharmaceutical/biopharmaceutical industry or equivalent.
• Experience managing GMP external contract test labs.

Mansioni

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

Descrizione del lavoro

Vertex Pharmaceuticals LLC is seeking a senior QC lead to coordinate QC activities at contract manufacturing and testing organizations, focusing on release testing, stability, and compliance with cGMP standards. You will manage reference standards, troubleshoot analytical methods, and lead investigations to drive continuous improvement.

The role requires a Bachelor's in science and roughly 8 years in the pharmaceutical/biopharmaceutical industry, with experience managing GMP external contract