Technical Quality Control Senior Manager - Casgevy

London (Paddington) Source: WhatJobs

See advert for pay

Overview

In this role you will lead QC activities for a gene-edited cell therapy program, coordinating with external labs to ensure compliant GMP release and stability testing. You will support commercial QC operations, drive lifecycle improvements for analytical methods, and oversee regulatory compliance in a hybrid London-based setting. You will partner with cross-functional teams to manage risks, investigations, and data integrity, enabling timely product release. This is a hands-on, impact-driven position at the intersection of quality, science, and regulatory compliance.

Pay / Benefits

Hybrid-Eligible
On-Site eligibility
ad hoc flexibility

Responsibilities

Lead QC activities at contract laboratories for release and stability testing, validation, and ensuring timelines
Manage QC operations for a gene-edited cell therapy product and troubleshoot analytical methods related to release
Oversee commercial reference standards and assay controls programs to ensure compliance and supply continuity
Troubleshoot analytical methods and equipment as needed
Author/review/approve data, SOPs, COAs, methods, protocols, and reports
Ensure external lab records comply with cGMP/GDP expectations
Lead compliance-focused teams for continuous improvement
Lead OOS/OOT investigations and assist with corrective actions

Key requirements

Bachelor's Degree in science or related discipline
Typically 8 years of pharmaceutical/biopharmaceutical experience
Experience managing GMP external contract test labs
Strong knowledge of US/EU cGMP regulations and some regulatory inspections experience
Experience with batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, and raw materials testing
Laboratory experience with assays related to release of biologics or cell therapies
Working knowledge of compendial safety testing for GMP drug products