Overview
The Quality Assurance (QA) Specialist will play a key role in supporting the QA team to ensure compliance with regulatory requirements related to the manufacture of gene therapies at the GTIMC facility. This position will contribute to maintaining MHRA inspection readiness and, once licensed, will support ongoing compliance to ensure the highest standards of product quality and patient safety.
Led by Professor Mimoun Azzouz, The GTIMC at Sheffield is dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases. The centre includes a purpose built GMP facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses (AAV) and provide all the necessary quality assurance and regulatory certification for human trials at NHS hospital sites. Located at the University of Sheffield’s Innovation District, the GTIMC is close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.
Main duties and responsibilities
* Assist in the development, implementation, and maintenance of quality systems, including document control, change control, deviation management, and risk assessment.
* Coordinate with cross-functional teams to ensure compliance with applicable regulatory guidelines, including but not limited to GMP, GLP, and other relevant quality standards.
* Collaborate with manufacturing and analytical teams to investigate and resolve product-related quality issues.
* Develop and implement corrective and preventive actions (CAPAs) to address identified non-compliance issues.
* Assist in the creation, review, approval, and maintenance of Standard Operating Procedures (SOPs), batch records, validation protocols, and other quality documentation.
* Assist and conduct internal audits and inspections to verify compliance with regulatory requirements and internal quality procedures.
* Ensure that all documentation is accurate, up-to-date, and readily accessible to relevant personnel.
* Support the investigation and resolution of customer complaints, deviations, and out-of-specification results.
* Identify opportunities for QA process improvement and collaborate with relevant stakeholders to implement quality enhancements.
* Participate in quality-related projects, including validation studies, process improvements, and risk assessments.
* To work as part of the wider GTIMC team, providing support as required to the other teams across the GTIMC facility as we work towards MHRA licensing.
* Understand cleanrooms and their associated regulation and regulators.
* Undertaking other tasks relating to the GTIMC as requested by the post’s line manager.
* As a member of staff, you will be encouraged to make ethical decisions in your role, embedding the University sustainability strategy into your working activities wherever possible.
* Carry out other duties, commensurate with the grade and remit of the post.
Qualifications and experience
* Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, or related field). An advanced degree is a plus. Relevant work experience in manufacturing capacity within gene therapy, biotechnology or other biological sciences.
* Proven ability to deliver in a GMP-licensed manufacturing facility, preferably in gene therapy or ATMPs.
* Working knowledge of regulatory requirements (MHRA) and quality standards (GMP, GDP and GLP).
* Experience with electronic quality systems (such as QPulse), document control, deviation management, change control and CAPA processes.
* Excellent attention to detail, problem-solving skills, and the ability to work effectively in a team-based environment.
* Deal with queries that require QA input to provide immediate support and problem resolution and escalate where required.
* Experience liaising with Manufacturing teams or Quality Control teams on activities such as batch record or test method review, technology transfer or validation.
* Ability to strictly adhere to written testing procedures while thinking critically and proposing changes where necessary.
* Experience in the oversight of Environmental Monitoring programs.
* Working knowledge of AAV manufacturing processes and release testing requirements.
Benefits and terms
Grade: 6
Salary: £32,080 - £36,636 per annum. Potential to progress to £39,906 per annum through sustained exceptional contribution.
Work arrangement: Full-time
Duration: Fixed Term Contract for 3 years.
Line Manager: Head of Quality
Direct Reports: Head of Quality
Our website: https://www.sheffield.ac.uk/gtimc
This role is laboratory based on site at the Gene Therapy Innovation and Manufacturing Centre GTIMC, Sheffield Business Park, S9 1ZA.
For informal enquiries about this job contact and for administration queries and details on the application process, contact the lead recruiter: gtimc@sheffield.ac.uk or on 0114 222 0654.
Next steps in the recruitment process
It is anticipated that the selection process will take place on Friday 3rd October. This will consist of an interview and a practical assessment. We plan to let candidates know if they have progressed to the selection stage on the week commencing 29th September. Contact Laura Haslam (l.haslam@sheffield.ac.uk) if you require any reasonable adjustments.
Disability and inclusion
We are a Disability Confident Employer. If you have a disability and meet the essential criteria you will be invited to interview.
We are a research university with a global reputation for excellence. Our ideas and expertise change the world for the better, making a real difference to society. Our University Vision outlines our commitment to building a diverse community of staff and students that recognises and values the abilities, backgrounds, beliefs and ways of living for everyone. More details can be found on our benefits page: sheffield.ac.uk/jobs/benefits.
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