We are looking for a Head of Quality Assurance to join a prestigious cell & gene therapy organisation based in Stevenage, Herts. You will take charge of a department of 15 people (4 direct reports), sign off a monthly QP report and have a heavily strategic role that focuses on future collaborative partners, new facilities, ongoing continuous improvement projects and furthering a culture of inspirational science and innovation.
This a permanent role with a highly competitive salary, plus an excellent benefits package. Full details will be disclosed on application.
Your role will include:
- Proactively ensuring that the company’s manufacturing centre meets the standards of both regulatory authorities (MHRA in particular) and new / existing external collaborators.
- Maintenance and continued development of the electronic QMS and monitoring compliance system.
- Leading the Quality team, made up of QA Leads, QA Specialists, the Validation group and the Training department.
- Hosting and conducting audits
- Undertake QP duties in compliance with Annex 16, including review and approval of monthly QP reports.
- Manage a GMP self-inspection programme.
You will work in partnership with a variety of internal and external collaborators, and this will be a pivotal role for the smooth running of GMP operations especially as the company continues to scale up its production capabilities for clinical / commercial biologicals, vaccines and cell or gene therapies.
Skills and Experience Required:
- Strong experience in aseptic Pharmaceutical manufacturing operations
- Eligible to act as a Qualified Person under the Permanent Provisions of 2001/83/EC (NB. You will also be considered if you are very close to completion or are awaiting the outcome of your viva)
- Lean six sigma green / black belt (desirable but not essential)
- Excellent communication skills and ability to work with people at all levels.
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire, paying an excellent salary plus benefits.