Senior Quality Officer

King's College London; City Of London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading educational institution in the UK is looking for a Senior Quality Officer to oversee compliance with quality standards in the manufacture of cell and gene-based products. The successful candidate will lead investigations and ensure adherence to Good Manufacturing Practice (GMP) and regulatory requirements. This full-time role provides an opportunity for professional growth in the Pharmaceutical Quality System.

Qualifications

• Experience in Quality Assurance within pharmaceutical or biotech sectors.
• Knowledge of UK and EU regulations relevant to GMP.
• Proficiency in conducting audits and investigations.

Responsibilities

• Ensure compliance with quality standards during product manufacture.
• Lead investigations into deviations and quality exceptions.
• Conduct internal and external audits.

Skills

Quality Assurance

Regulatory compliance

Deviation investigation

Audit preparation

Education

Relevant degree in a scientific field

Job description

Overview

The Senior Quality Officer will work within the Quality Assurance team (QA) to ensure all activities within the Cell and Gene Therapy (CGT) group related to the manufacture, import, testing and release of cell and gene based products meet the quality standards of the CGT 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. They 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 perform the QA sign off of operator validations and carry out initial reviews of Batch Manufacturing Records, Quality Control Records and Media Fill Records. Participation in the conduct 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 take day to day responsibility for the 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 Cell and Gene Therapy 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 post will be offered on an indefinite contract. This is a full-time post.