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    • This Quality Control Lead role offers a permanent position in West, London, overseeing QC operations for a stem cell therapy manufacturing facility.
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Head of Quality Control
Actionus
West London
£80,000 - £100,000 a year
Permanent, Full-time
Apply now

Job details

Here’s how the job details align with your profile.

Pay

£80,000 - £100,000 a year

Job type

Permanent
Full-time

Full job description

The role

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.

Send your CV or contact Actionus for further details.

Pay: £80,000.00-£100,000.00 per year

Application question(s):

  • Have you previously been formally named/approved as the person responsible for QC on an MHRA Manufacturer's Specials (MS or MIA) licence?
  • Can you confirm if you would meet the current MHRA eligibility requirements to be named in that role?
  • Do you have any experience in cell and gene therapy or sterile and aseptic ATMP environments?

Work Location: In person

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