Senior Quality Officer

Job title:

Senior Quality Officer

Company:

King’s College London

Job description

About usThe King’s College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages.In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.The GTVF is run by a large, industry-leading team of
50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trialsAbout the roleThe Senior Quality Officer will work within the Quality Assurance team (QA) to ensure all activities within the GTVF group related to the manufacture, testing and release of GMP grade viral vectors meet the quality standards of the GTVF group as outlined in the Quality Manual and external standards e.g. UK statutory instruments, EU Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) regulations.The Senior Quality Officer will take a lead role in the investigation and closeout of deviations and quality exceptions in conjunction with the Production and QC teams including determining corrective and preventative actions and monitoring their progress. They will lead on supplier qualification perform the QA sign off of operator validations and carry out initial reviews of Batch Manufacturing Records, Quality Control Records and Media Fill Records.Lead internal and external audits including preparation of checklists, preparation of audit reports, review of proposed corrective actions and follow up on completion and closeout of the audit will form a key aspect of the role. In addition, the Senior Quality Officer will perform authorisation of the manufacturing suites for use.The Senior Quality Officer will work closely with the Head of Quality and Quality managers to drive continuous improvement of the Pharmaceutical Quality System and will be an integral member of the Quality Assurance team and work with team members across the whole of the GTVF group including R&D, Production, Technical and Quality Control. The Senior Quality Officer will be responsible to the Head of Quality.This position provides an opportunity to develop a good understanding of a wide range of cell and gene therapy and Pharmaceutical Quality Systems.This is a full-time post (35 hours per week), and you will be offered an indefinite contract.About youTo be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria * Working knowledge of a Pharmaceutical Quality System according to ICH Q10 in particular Change Control, Document Control, Deviations and CAPA, and supplier qualification. Deliver Good Manufacturing Practice training.

• Experience of working in an ATMP/ IMP / Biopharm / Vaccines manufacturing setting.
• Experience in operational QA e.g., review pre-executed batch records, executed batch records and validations or media fills.
• Experience in performing supplier qualification including supplier audits
• Experience in performing and managing internal and external audits
• Excellent organisational skills with a demonstrable ability to balance competing demands and priorities. Good verbal and written communication skills.

Desirable criteria * Experience in working a MHRA / HTA / FDA licenced environment.

• Hands on experience in production or QC of cell therapies or cell biology / immunology-based research / vaccines.

Downloading a copy of our Job DescriptionFull details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply Now”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.Further informationThis post is subject to Disclosure and Barring Service clearance.We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King’s. We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.To find out how our managers will review your application, please take a look at our ‘ ‘ pages.We are not able to offer sponsorship for candidates who do not currently possess the right to work in the UK.

Expected salary

£43205 – 50585 per year

Location

Strand, Central London

Job date

Fri, 09 Aug 2024 02:23:48 GMT

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