Senior CMC and Quality Leader

This Senior CMC and Quality Leader role is a permanent position based in West London prime location, London, at a new gene therapy and stem cell laboratory. You will lead the regulatory strategy and quality systems for biologics and cell and gene therapy products, taking projects from early development through to clinical stages within a sterile manufacturing environment.

Responsibilities

• Lead CMC strategy and regulatory dossier writing including IND and IMPD documentation for clinical programmes.
• Manage CDMO and vendor relationships to ensure alignment between manufacturing processes and quality requirements.
• Oversee the design and qualification of GMP QC laboratories and clean rooms to meet MHRA licensing standards.
• Build and develop multidisciplinary quality teams across QC, QA, analytical development, and validation functions.
• Experience to Implement and manage electronic quality systems such as Veeva eQMS, Labware, and STARLIMS.
• Design and execute Grade A to D environmental monitoring programmes and contamination control strategies.

What you'll need

• Extensive CMC, GMP, and QA operational experience within the life sciences sector.
• Significant experience in management and leadership roles within a laboratory or manufacturing setting.
• Proven track record in biologics and cell and gene therapy product development.
• Expertise in regulatory inspection readiness and experience with MHRA inspections.
• Deep understanding of sterile manufacturing and analytical control strategies.
• Strong background in facility and equipment validation for GMP environments.