Quality Control Lead

This Quality Control Lead role offers a permanent position in West, London, overseeing QC operations for a stem cell therapy manufacturing facility. You will be responsible for scaling a new team, quality control and final product release under an MHRA Manufacturer Specials licence, ensuring full compliance with GMP Annex 1 and HTA requirements. The successful candidate will establish approved licence status, environmental monitoring programmes and validate QC systems for advanced therapy manufacturing.

Responsibilities

• Establish and oversee cleanroom environmental monitoring programmes aligned with MHRA GMP Annex 1 standards.
• Develop and execute QC testing protocols including sterility, mycoplasma, endotoxin, and cell characterisation.
• Lead qualification and validation activities for Grade A to D cleanroom environments including air and water testing.
• Review batch records and sign off finished product release in line with MHRA requirements for specials manufacturing.
• Manage raw material testing, release protocols, and stability studies for stem cell lines under HTA guidelines.
• Lead investigations into out of specification results, performing root cause analysis and implementing CAPAs.
• Represent the QC department and processes during formal MHRA and HTA regulatory inspections.

What you'll need

• Degree in pharmacy, microbiology, biotechnology, or a closely related life science discipline.
• Minimum of 5 years practical experience in a GMP regulated manufacturing environment under MHRA oversight.
• Extensive hands on experience with human cell culture, stem cell lines, and aseptic techniques.
• Detailed knowledge of cleanroom qualification and environmental monitoring adhering to GMP Annex 1.
• Proven experience preparing laboratories for HTA inspections and maintaining HTA licensing readiness.
• Eligibility to be named as the person responsible for QC on an MHRA MS or MIA licence.
• Standard DBS clearance for working within regulated life science environments.