Contract QA Manager in Hertfordshire
Graeme Pallas at CK Science is recruiting for a contract Quality Assurance (QA) Manager to join a multinational clinical-stage cell & gene therapy research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a 3-6 month contract role based in Hertfordshire (20 minutes North of London via train).
The Company: The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe and places a strong emphasis on innovation to make a difference to patients lives. Their gene therapy treatment builds upon their own pioneering work and their proprietary product which has already transformed the lives of patients by providing a safe, effective and reliable gene therapy
The Role: As the contract QA Manager you will be leading QA support for GMP manufacturing activities whilst providing QA oversight of work executed at third party GMP manufacturing and testing service providers. You will provide QA input into Change Controls, Deviations, OOS reports & CAPAs, lead quality investigations, perform risk assessments and review CMC sections of regulatory filings. Other duties will include internal audits of manufacturing & testing facilities, external audits of GMP service providers, reviewing executed batch manufacturing, QC and stability records, reviewing & approving the qualification, validation and tech transfer of activities and supporting competent authority inspections (MHRA and US FDA).
Your Background: Educated to degree level or equivalent in a biological or physical science you will have Quality Assurance experience gained in the pharmaceutical/biotech industry along with GMP & biologics experience. With a thorough understanding of biologics or ATMPs manufacturing for clinical development and prior experience auditing contract manufacturers and suppliers you will fully utilise your excellent planning, organisational and interpersonal skills to excel in this role. The ability to travel to work partners in Europe and US is required and any GCP/GCLP and/or experience of implementing electronic document management systems would be advantageous.
For more information or to apply for this QA Manager position, please contact Graeme Pallas on 0191 384 8905 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44647 in all correspondence.