Technical Quality Control Senior Manager (Casgevy)

Location: Paddington, London, United Kingdom; hybrid with remote work up to two days per week or on-site five days per week

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of medicines for patients.

What you will do

• Lead QC activities with external contract manufacturing and testing organizations, including release and stability testing, equipment and software validation, and project timelines.
• Manage QC operations for a gene-edited hemoglobinopathy cell therapy product and troubleshoot analytical methods for biologics and cell therapy release.
• Manage commercial reference standards and assay control programs to support compliance and continuity of supply.
• Author, review, and approve data, SOPs, certificates of analysis, analytical methods, protocols, and reports.
• Ensure external laboratory records comply with cGMP and GDP expectations.
• Lead OOS/OOT investigations, deviations, corrective actions, and continuous improvement activities.

Requirements

• Bachelor’s degree in science or a related discipline.
• Typically 8 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
• Experience managing GMP external contract testing laboratories.
• Strong knowledge of US and EU cGMP regulations and guidance, with some experience supporting regulatory agency inspections.
• Experience with several of the following: batch release, OOS/OOT investigations, reference standards and assay controls, stability studies, LIMS, and raw materials testing.
• Laboratory experience with assays for biologics or cell and gene therapies, plus working knowledge of compendial assays and GMP drug-product safety testing.

Culture & Benefits

• Hybrid-eligible or on-site-eligible work arrangement under the Flex program.
• Continuous learning focused on AI, technology, automation, and industry developments.
• Opportunity to improve decision-making, efficiency, and patient outcomes through new capabilities.